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510(k) K971075

PRIMED PRIME-PLUS COTTON GAUZE SPONGES by Primeline Medical Products, Inc. — Product Code EFQ

K971075 is an FDA 510(k) premarket notification submitted by Primeline Medical Products, Inc. for the device "PRIMED PRIME-PLUS COTTON GAUZE SPONGES". The FDA issued a decision of Substantially Equivalent on June 22, 1997. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Primeline Medical Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1997
Date Received
March 24, 1997
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 Primeline Medical Products, Inc.

  • K022868 — PRIMAGARD SURGICAL EQUIPMENT DRAPES (November 8, 2002)
  • K023266 — PRIMAGARD SURGICAL GOWNS (November 8, 2002)
  • K023117 — PRIMAGARD SURGICAL GOWNS (November 8, 2002)
  • K021864 — PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1- (September 23, 2002)
  • K021076 — PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGI (April 16, 2002)
  • K011789 — PROCEDURE MASKS: PM4-301 AND PM4-304 (June 22, 2001)
  • K001951 — PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCED (September 8, 2000)
  • K971076 — PRIMED SHOE COVERS, PRIMED HEAD COVERS (January 13, 1998)

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