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510(k) K960093

PROTEC ROLL GAUZE by Derivadas Degasa S.A. DE C.V. — Product Code EFQ

K960093 is an FDA 510(k) premarket notification submitted by Derivadas Degasa S.A. DE C.V. for the device "PROTEC ROLL GAUZE". The FDA issued a decision of Substantially Equivalent on March 25, 1996. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Derivadas Degasa S.A. DE C.V. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1996
Date Received
January 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Derivadas Degasa S.A. DE C.V.

  • K961773 — PROTEC STERILE GAUZE SPONGE (July 29, 1996)
  • K955320 — PROTEC COTTON PADDING BANDAGE (January 26, 1996)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)

FDA data resources