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510(k) K861338

DENTAL COTTON ROLLS, STERILE AND NON-STERILE by Intl. Verbandstoff-Fabrik Schaffhau — Product Code EFN

K861338 is an FDA 510(k) premarket notification submitted by Intl. Verbandstoff-Fabrik Schaffhau for the device "DENTAL COTTON ROLLS, STERILE AND NON-STERILE". The FDA issued a decision of Substantially Equivalent on August 6, 1986. 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
August 6, 1986
Date Received
April 7, 1986
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

  • K841327 — DENTAL COTTON ROLLS (July 3, 1984)

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)
  • 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)

FDA data resources