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510(k) K030774

STIMULEN COLLAGEN by Southwest Technologies, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2004
Date Received
March 11, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Southwest Technologies, Inc.

  • K102478 — OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING (November 3, 2010)
  • K083334 — ELASTO-GEL MANUKA HONEY WOUND DRESSING (July 30, 2009)
  • K872488 — ELASTO-GEL CAST & SPLINT PADS (September 21, 1987)
  • K872165 — ELASTO-GEL OCCLUSIVE DRESSING (June 26, 1987)

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  • K250397 — Helios Dermal Scaffold (August 15, 2025)
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