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510(k) K841327

DENTAL COTTON ROLLS by Intl. Verbandstoff-Fabrik Schaffhau — Product Code EFN

K841327 is an FDA 510(k) premarket notification submitted by Intl. Verbandstoff-Fabrik Schaffhau for the device "DENTAL COTTON ROLLS". The FDA issued a decision of Substantially Equivalent on July 3, 1984. The device falls under product code EFN (Cotton, Roll), a Class I device regulated under 21 CFR 872.6050. Intl. Verbandstoff-Fabrik Schaffhau has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1984
Date Received
April 2, 1984
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 Intl. Verbandstoff-Fabrik Schaffhau

  • K861338 — DENTAL COTTON ROLLS, STERILE AND NON-STERILE (August 6, 1986)

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)
  • 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)

FDA data resources