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510(k) K872069

KONTOUR ULTRA SOFT SPONGE #SS144.50 by Winfield Laboratories, Inc. — Product Code NAD

K872069 is an FDA 510(k) premarket notification submitted by Winfield Laboratories, Inc. for the device "KONTOUR ULTRA SOFT SPONGE #SS144.50". The FDA issued a decision of SN on July 14, 1987. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Winfield Laboratories, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
July 14, 1987
Date Received
May 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances by Winfield Laboratories, Inc.

  • K973538 — N-TERFACE (December 16, 1997)
  • K923602 — ABSORBENT PAD -- MODIFICATION (December 7, 1992)
  • K820198 — DERMA-AID (March 5, 1982)

Other clearances for product code NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)

FDA data resources