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510(k) K872810

STRUNG DENTAL ROLLS by American Silk Sutures, Inc. — Product Code EFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1987
Date Received
July 14, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cotton, Roll
Device Class
Class I
Regulation Number
872.6050
Review Panel
DE
Submission Type

Other clearances by American Silk Sutures, Inc.

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  • K904514 — STRUNG TELFA NON-ADHERENT SPONGE (March 27, 1991)
  • K902921 — RAYON NEUROLOGICAL SPONGE (September 18, 1990)
  • 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)
  • K872807 — NON-WOVEN TRACHEOTOMY SPONGE (August 4, 1987)
  • K872809 — GAUZE CHERRY SPONGE (August 4, 1987)
  • K872806 — STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG (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 EFN

  • K871464 — MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER (April 30, 1987)
  • K863764 — COTTON ROLLS, NON-STERILE (October 27, 1986)
  • K861338 — DENTAL COTTON ROLLS, STERILE AND NON-STERILE (August 6, 1986)
  • K861727 — COTTON FILLED GAUZE SPONGES 2 X 2 (July 10, 1986)
  • K843539 — TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- (May 23, 1985)
  • K841327 — DENTAL COTTON ROLLS (July 3, 1984)
  • K834056 — SCHEIN COTTON ROLLS, NON-STERILE (February 3, 1984)
  • K830175 — STERILE COTTON ROLLS #3, 1 1/2 (February 18, 1983)
  • K812709 — STERILE DENTAL ROLL (October 23, 1981)
  • K810830 — HOYT COTTON ROLLS (April 14, 1981)