FDA 510(k) Application Details - K962288

Device Classification Name Cover, Barrier, Protective

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510(K) Number K962288
Device Name Cover, Barrier, Protective
Applicant PINNACLE PRODUCTS, INC.
624 SOUTH SMITH AVE.
ST. PAUL, MN 55107 US
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Contact THOMAS LASING
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Regulation Number 878.4370

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Classification Product Code MMP
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Date Received 06/14/1996
Decision Date 01/30/1997
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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