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510(k) K102002

TALYMED by Marine Polymer Technologies — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2010
Date Received
July 15, 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

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  • K984177 — MODIFICATION TO SKVEKPATCH (December 18, 1998)
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