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510(k) K830175

STERILE COTTON ROLLS #3, 1 1/2 by Veratex Corp. — Product Code EFN

K830175 is an FDA 510(k) premarket notification submitted by Veratex Corp. for the device "STERILE COTTON ROLLS #3, 1 1/2". The FDA issued a decision of Substantially Equivalent on February 18, 1983. The device falls under product code EFN (Cotton, Roll), a Class I device regulated under 21 CFR 872.6050. Veratex Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1983
Date Received
January 18, 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

Other clearances by Veratex Corp.

  • K801032 — STERILE DRAPE 17X18 CODE D-6A (May 20, 1980)
  • K801033 — STERILE DRAPE 17X18 W/3 FENESTRATION (May 20, 1980)

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)
  • K834056 — SCHEIN COTTON ROLLS, NON-STERILE (February 3, 1984)
  • K812709 — STERILE DENTAL ROLL (October 23, 1981)
  • K810830 — HOYT COTTON ROLLS (April 14, 1981)

FDA data resources