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510(k) K914431

ABSORBENT FIBER by Ulti-Med Intl., Inc. — Product Code NAB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1991
Date Received
October 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze / Sponge,Nonresorbable For External Use
Device Class
Class I
Regulation Number
878.4014
Review Panel
SU
Submission Type

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  • K920989 — SURGICAL INSTRUMENT KIT, DISPOSABLE (October 19, 1992)
  • K922828 — ULCER WOUND TRAY (September 28, 1992)
  • K914244 — STERILE CUSTOM SURGICAL KITS (February 24, 1992)
  • K912692 — CONFORMING BANDAGE (October 4, 1991)
  • K912693 — POST OPERATIVE SPONGE (October 4, 1991)
  • K904896 — EYE PAD (December 5, 1990)
  • K901465 — ABSORBABLE GAUZE DRAPE (June 12, 1990)

Other clearances for product code NAB

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  • K925590 — MULTI-TRAUMA DRESSING (April 8, 1993)
  • K926072 — K-BAND AND K-CREPE (March 19, 1993)
  • K915591 — STERILE GAUZE PADS (January 27, 1993)
  • K924650 — GAUZE SPONGES (January 11, 1993)
  • K923602 — ABSORBENT PAD -- MODIFICATION (December 7, 1992)
  • K923115 — CLINISORB (November 23, 1992)
  • K923378 — USP TYPE VII GAUZE SPONGES (October 6, 1992)