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510(k) K781420

SPECIALTY SPONGES by Ipco Corp. — Product Code EFQ

K781420 is an FDA 510(k) premarket notification submitted by Ipco Corp. for the device "SPECIALTY SPONGES". The FDA issued a decision of Substantially Equivalent on October 3, 1978. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Ipco Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1978
Date Received
August 15, 1978
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 Ipco Corp.

  • K871270 — PERFORM DENTURE BASE RESIN (May 29, 1987)
  • K850666 — STROBEX ULTRON ELECTROSURGE-DENTAL UNIT (May 29, 1985)
  • K850906 — TACTILE PLUS DENTAL ELEVATORS (April 12, 1985)
  • K842836 — SAFE & SOFT MINI PADS & MAXI PADS (October 15, 1984)
  • K842837 — SAFE & SOFT MAXI SHILEDS (October 15, 1984)
  • K842838 — SAFE & SOFT PANTY SHIELDS (October 5, 1984)
  • K841953 — ULTRA SHIELD BRIEFS (July 19, 1984)
  • K840753 — AMBEZE DISPOSABLE INCONTINENCE PANTS (April 13, 1984)
  • K840754 — MAXISHIELD INCONTINENCE CARE SYSTEM (April 13, 1984)
  • K840755 — MINIGARD DISPOSABLE LINERS (April 13, 1984)

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