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510(k) K861727

COTTON FILLED GAUZE SPONGES 2 X 2 by Cross Country Paper Products Corp. — Product Code EFN

K861727 is an FDA 510(k) premarket notification submitted by Cross Country Paper Products Corp. for the device "COTTON FILLED GAUZE SPONGES 2 X 2". The FDA issued a decision of Substantially Equivalent on July 10, 1986. The device falls under product code EFN (Cotton, Roll), a Class I device regulated under 21 CFR 872.6050. Cross Country Paper Products Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1986
Date Received
May 6, 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 Cross Country Paper Products Corp.

  • K941327 — CROSSTEX SELF-SEALING STERILIZATION POUCH (December 22, 1994)
  • K844759 — SURGICAL SCALPEL BLADES & DISPOSABLES (January 18, 1985)

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)
  • 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