FDA 510(k) Application Details - K020435

Device Classification Name Drape, Surgical

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510(K) Number K020435
Device Name Drape, Surgical
Applicant APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
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Contact ANIL BHALANI
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 02/08/2002
Decision Date 04/15/2002
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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