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510(k) K110715

INTERDRY SILVER by Milliken Healthcare Products, LLC — Product Code FRL

K110715 is an FDA 510(k) premarket notification submitted by Milliken Healthcare Products, LLC for the device "INTERDRY SILVER". The FDA issued a decision of Substantially Equivalent on November 4, 2011. The device falls under product code FRL (Fiber, Medical, Absorbent), a Class I device regulated under 21 CFR 880.5300. Milliken Healthcare Products, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2011
Date Received
March 15, 2011
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 Milliken Healthcare Products, LLC

  • K141603 — Ultra Silver Dressings (October 22, 2014)
  • K103141 — LOW ADHERENT AFM AG DRESSINGS (January 21, 2011)

Other clearances for product code FRL

  • K121898 — STAY FRESH SKIN FOLD MANAGEMENT TEXTILE (May 24, 2013)
  • 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