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510(k) K933085

GOODMAN BANDAGE by Megadyne Medical Products, Inc. — Product Code KGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1993
Date Received
June 23, 1993
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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Other clearances for product code KGY

  • K913678 — TROCAR CATHETER (December 16, 1991)
  • K910914 — SURGICAL TISSUE POUCH (March 28, 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)