FDA 510(k) Application Details - K013324

Device Classification Name Surgeon'S Gloves

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510(K) Number K013324
Device Name Surgeon'S Gloves
Applicant TILLOTSON HEALTHCARE CORP.
360 ROUTE 101 W
BEDFORD, NH 03110 US
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Contact F.W. PERRELLA
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 10/05/2001
Decision Date 11/29/2001
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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