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510(k) K880909

TRACHEOTOMY SPONGES by Ormed Mfg., Inc. — Product Code EFQ

K880909 is an FDA 510(k) premarket notification submitted by Ormed Mfg., Inc. for the device "TRACHEOTOMY SPONGES". The FDA issued a decision of Substantially Equivalent on March 17, 1988. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Ormed Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1988
Date Received
March 3, 1988
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 Ormed Mfg., Inc.

  • K931555 — ARTROMOT K2 CPM (January 31, 1994)
  • K882527 — GAUZE SPONGE (July 18, 1988)
  • K882530 — TAPE STRUNG TONSIL SPONGE (July 18, 1988)
  • K882529 — BUTCHER STRUNG TONSIL SPONGE (July 18, 1988)
  • K882528 — CYLINDRICAL SPONGE (July 18, 1988)
  • K880851 — FLAT STICK SPONGE (March 17, 1988)
  • K880852 — ROSEBUD DISSECTORS (March 17, 1988)
  • K880853 — CHERRY SPONGE (March 17, 1988)
  • K880907 — TRIANGLE SPONGE (March 17, 1988)
  • K880910 — ROUND STICK SPONGES (March 17, 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