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510(k) K083334

ELASTO-GEL MANUKA HONEY WOUND DRESSING by Southwest Technologies, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2009
Date Received
November 12, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
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)
  • K030774 — STIMULEN COLLAGEN (August 9, 2004)
  • K872488 — ELASTO-GEL CAST & SPLINT PADS (September 21, 1987)
  • K872165 — ELASTO-GEL OCCLUSIVE DRESSING (June 26, 1987)

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