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510(k) K973580

INVOTEC CLEAN PAD by Invotec International, Inc. — Product Code EFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1997
Date Received
September 19, 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

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  • K973578 — INVOTEC EAR TAMPON (WICK) W/STRING (November 6, 1997)
  • K971000 — EPISTAXIS NASAL PACK (May 14, 1997)
  • K930114 — TRACHEOSTOMY T-TUBE (March 19, 1993)
  • K911041 — INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE (June 4, 1991)
  • K911040 — INVOTEC MICROSCOPE DRAPE (June 3, 1991)
  • K911039 — INVOTEC EAR DRAPE (May 13, 1991)
  • K901923 — INVOTEC POLY-MESH MANDIBULAR TRAY (October 31, 1990)

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)