FDA 510(k) Application Details - K990042

Device Classification Name Dressing, Wound, Drug

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510(K) Number K990042
Device Name Dressing, Wound, Drug
Applicant BIO MED SCIENCES, INC.
101 TECHNOLOGY DR.
BETHLEHEM, PA 18015 US
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Contact MARK E DILLON
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 01/06/1999
Decision Date 03/19/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K990042


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