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510(k) K854714

X-RAY DETECTABLE COTTON BALLS by American Silk Sutures, Inc. — Product Code GDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1985
Date Received
November 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal, X-Ray Detectable
Device Class
Class I
Regulation Number
878.4450
Review Panel
SU
Submission Type

Other clearances by American Silk Sutures, Inc.

  • K922143 — AMERICAN BURN SHEET (August 10, 1992)
  • K904514 — STRUNG TELFA NON-ADHERENT SPONGE (March 27, 1991)
  • K902921 — RAYON NEUROLOGICAL SPONGE (September 18, 1990)
  • K872810 — STRUNG DENTAL ROLLS (December 4, 1987)
  • K872951 — AMERICAN BRAIN RETRACTOR COVER (September 16, 1987)
  • K872905 — AMERICAN NASAL SPONGE (September 4, 1987)
  • K872906 — SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE (August 11, 1987)
  • K872809 — GAUZE CHERRY SPONGE (August 4, 1987)
  • K872807 — NON-WOVEN TRACHEOTOMY SPONGE (August 4, 1987)
  • K872808 — CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8 (August 4, 1987)

Other clearances for product code GDY

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  • K960236 — CPR LAP SPONGES (March 28, 1996)
  • K955599 — STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE (February 22, 1996)
  • K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE (December 19, 1995)
  • K953830 — KENSORB (October 3, 1995)
  • K953058 — ROUND STICK SPONGES, FLAT STICK SPONGES (September 14, 1995)
  • K953060 — ROSEBUD DISSECTOR (September 14, 1995)
  • K953087 — CHERRY PIT DISSECTOR (September 14, 1995)
  • K953062 — CHERRY DISSECTOR (September 14, 1995)
  • K953057 — CYLINDRICAL SPONGE (September 14, 1995)