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510(k) K802429

COTTON ROLLS by Worldwide Surgical Gauze — Product Code EFN

K802429 is an FDA 510(k) premarket notification submitted by Worldwide Surgical Gauze for the device "COTTON ROLLS". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code EFN (Cotton, Roll), a Class I device regulated under 21 CFR 872.6050. Worldwide Surgical Gauze has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
October 3, 1980
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 Worldwide Surgical Gauze

  • K823455 — SURGICAL GAUZE (January 28, 1983)
  • K812572 — GAUZE SPONGES (November 2, 1981)
  • K803172 — GAUZE SPONGES (January 15, 1981)

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)
  • K830175 — STERILE COTTON ROLLS #3, 1 1/2 (February 18, 1983)
  • K812709 — STERILE DENTAL ROLL (October 23, 1981)

FDA data resources