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510(k) K121898

STAY FRESH SKIN FOLD MANAGEMENT TEXTILE by Quick-Med Technologies, Inc. — Product Code FRL

K121898 is an FDA 510(k) premarket notification submitted by Quick-Med Technologies, Inc. for the device "STAY FRESH SKIN FOLD MANAGEMENT TEXTILE". The FDA issued a decision of Substantially Equivalent on May 24, 2013. The device falls under product code FRL (Fiber, Medical, Absorbent), a Class I device regulated under 21 CFR 880.5300. Quick-Med Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2013
Date Received
June 29, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fiber, Medical, Absorbent
Device Class
Class I
Regulation Number
880.5300
Review Panel
HO
Submission Type

Other clearances by Quick-Med Technologies, Inc.

  • DEN070002 — QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING (February 25, 2009)

Other clearances for product code FRL

  • K110715 — INTERDRY SILVER (November 4, 2011)
  • K061615 — INTERDRY TEXTILE WITH SILVER (December 22, 2006)
  • K931626 — CARAPACE STERILE COTTON BALLS (December 2, 1993)
  • K914081 — ICAN COTTON RAYON BALLS (October 9, 1991)
  • K811990 — TRACH CLEANING TRAY (July 27, 1981)
  • K810242 — UTENSIL & PROCEDURE TRAYS (April 15, 1981)
  • K800277 — MEDSPEC RAYON BALLS (March 12, 1980)
  • K800249 — SURGITEK FOERSTER MAMMARY BANDAGE (February 19, 1980)
  • K800248 — SURGITEK FOERSTER FACE LIFT BANDAGE (February 19, 1980)
  • K792295 — SORBIES (December 20, 1979)

FDA data resources