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510(k) K910914

SURGICAL TISSUE POUCH by Cook Urological, Inc. — Product Code KGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1991
Date Received
March 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Intestine
Device Class
Class I
Regulation Number
878.4100
Review Panel
SU
Submission Type

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  • K080525 — COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W (April 17, 2008)
  • K073496 — OPTILITE HOLMIUM LASER FIBERS (January 23, 2008)
  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
  • K061371 — SYDNEY IVF SPERM CRYOPRESERVATION BUFFER (August 17, 2006)

Other clearances for product code KGY

  • K933085 — GOODMAN BANDAGE (December 23, 1993)
  • K913678 — TROCAR CATHETER (December 16, 1991)
  • K832318 — ISOLATION BAG 3M (October 31, 1983)
  • K801824 — BAND-AID BRAND FLEXIBLE FABRIC BANDAGE (August 20, 1980)
  • K801823 — BAND-AID BRAND TRICOT MESH BANDAGES (August 20, 1980)