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510(k) K102478

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2010
Date Received
August 30, 2010
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.

  • K083334 — ELASTO-GEL MANUKA HONEY WOUND DRESSING (July 30, 2009)
  • 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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