FDA 510(k) Application Details - K935189

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K935189
Device Name Dressing, Wound, Collagen
Applicant BRENNEN MEDICAL, INC.
1290 HAMMOND RD.
ST. PAUL, MN US
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Contact JEFFREY M WILLIAMS
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 10/26/1993
Decision Date 07/11/1994
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee -
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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