FDA 510(k) Application Details - K991548

Device Classification Name Drape, Surgical

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510(K) Number K991548
Device Name Drape, Surgical
Applicant NOVED MEDICAL
168 AVENIDA DEL MAR, SUITE 120
SAN CLEMENTE, CA 92672 US
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Contact MIKE GRIFFIN
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 05/03/1999
Decision Date 06/23/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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