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510(k) K893902

4 X 4 STERILE GAUZE SPONGE TRAY by Mumtaz I. Malik — Product Code EFQ

K893902 is an FDA 510(k) premarket notification submitted by Mumtaz I. Malik for the device "4 X 4 STERILE GAUZE SPONGE TRAY". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Mumtaz I. Malik has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1989
Date Received
May 30, 1989
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 Mumtaz I. Malik

  • K901511 — CHISEL, BONE, SURGICAL (September 28, 1990)
  • K901289 — RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS (September 28, 1990)
  • K901521 — OSTEOTOMES OF VARIOUS TYPES (September 28, 1990)
  • K901420 — VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8 (September 28, 1990)
  • K890071 — STERILE LACERATION TRAY (January 24, 1989)
  • K884195 — GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) (October 24, 1988)

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