Springfield, Missouri Roi, Consolidated Service Center (CSC) deals with medical kits and trays. Our product line comprises of angiography/angioplasty, burn kit without drug, cardiac catheterization, cardiovascular procedure, cesarean section and custom anesthesia kits. We also provide throat surgical tray, eye tray, gene More...
+1-(314)-6283849
Mundelein, Illinois Medline Industries, Inc. is a manufacturer and distributor of health care supplies & services. We provide products and services to the entire continuum of care, including hospitals, extended care facilities, surgery centers, commercial laundries, home care dealers, home care agencies, physician offi More...
www.medline.com
Cesarean Section Kit Manufacturers
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.
Classification. (1) Class II (performance standards).
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
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