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510(k) K082208

DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER by Scivolutions, Inc. — Product Code NAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2008
Date Received
August 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Hydrophilic
Device Class
Class I
Regulation Number
878.4018
Review Panel
SU
Submission Type

Other clearances by Scivolutions, Inc.

  • K020318 — SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES (February 3, 2003)

Other clearances for product code NAC

  • K925841 — HYDRASORB JOYCE SPONGE (May 12, 1993)
  • K914779 — ALGINATE FIBER (December 4, 1991)
  • K914575 — SORBSAN TOPICAL WOUND DRESSING (MODIFIED) (December 4, 1991)