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510(k) K843539

TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- by Molnlycke A/S Hospital Products — Product Code EFN

K843539 is an FDA 510(k) premarket notification submitted by Molnlycke A/S Hospital Products for the device "TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-". The FDA issued a decision of Substantially Equivalent on May 23, 1985. The device falls under product code EFN (Cotton, Roll), a Class I device regulated under 21 CFR 872.6050. Molnlycke A/S Hospital Products has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1985
Date Received
September 7, 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 Molnlycke A/S Hospital Products

  • K861250 — MESULIN, INSULIN INFUSION SET (May 23, 1986)
  • K833398 — MESULIN INSULIN INFUSION SET (March 6, 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)
  • K861338 — DENTAL COTTON ROLLS, STERILE AND NON-STERILE (August 6, 1986)
  • K861727 — COTTON FILLED GAUZE SPONGES 2 X 2 (July 10, 1986)
  • 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