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510(k) K834056

SCHEIN COTTON ROLLS, NON-STERILE by Henry Schein, Inc. — Product Code EFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1984
Date Received
November 23, 1983
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

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  • K841199 — FIBERGLASS MOUTH MIRRORS (April 25, 1984)
  • K834055 — VANADIUM EXCAVATORS SIZES 0-6 (February 21, 1984)
  • K801079 — KWIX-BITE X-RAY FILM HOLDER (May 20, 1980)
  • K781592 — SURGICAL ASPIRATOR TIPS (December 4, 1978)

Other clearances for product code EFN

  • K872810 — STRUNG DENTAL ROLLS (December 4, 1987)
  • 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)
  • 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)