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510(k) K871464

MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER by Medgroup Enterprises, Inc. — Product Code EFN

K871464 is an FDA 510(k) premarket notification submitted by Medgroup Enterprises, Inc. for the device "MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER". The FDA issued a decision of Substantially Equivalent on April 30, 1987. The device falls under product code EFN (Cotton, Roll), a Class I device regulated under 21 CFR 872.6050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1987
Date Received
April 14, 1987
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 for product code EFN

  • K872810 — STRUNG DENTAL ROLLS (December 4, 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)
  • K810830 — HOYT COTTON ROLLS (April 14, 1981)

FDA data resources