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510(k) K874067

GUAZE SPONGES by Interpro Intl., Inc. — Product Code EFQ

K874067 is an FDA 510(k) premarket notification submitted by Interpro Intl., Inc. for the device "GUAZE SPONGES". The FDA issued a decision of Substantially Equivalent on December 14, 1987. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Interpro Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1987
Date Received
October 5, 1987
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 Interpro Intl., Inc.

  • K890968 — VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX) (July 31, 1989)
  • K891642 — PATIENT EXAMINATION GLOVES (LATEX) (July 14, 1989)
  • K890891 — LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL) (July 14, 1989)
  • K891440 — PATIENT EXAMINATION GLOVES (LATEX) (May 31, 1989)
  • K891438 — PATIENT EXAMINATION GLOVES (LATEX) (May 31, 1989)
  • K881374 — SURGEONS GLOVES (August 5, 1988)
  • K874766 — INTERPRO INT'L, INC. ISOLATION GOWN (December 10, 1987)
  • K874065 — LAPAROTOMY SPONGES (November 4, 1987)
  • K874066 — SURGICAL CAPS (November 4, 1987)
  • K874064 — SHOE COVERS (November 4, 1987)

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