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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K913536
Device Name PRC AUTOPSY DEVICE
Applicant
PENNSTATE
306 W. COLLEGE AVE.
THE PENSYLVANIA STATE UNIVERSI
UNIVERSITY PARK,  PA  16801
Applicant Contact THOMAS MONAHAN
Correspondent
PENNSTATE
306 W. COLLEGE AVE.
THE PENSYLVANIA STATE UNIVERSI
UNIVERSITY PARK,  PA  16801
Correspondent Contact THOMAS MONAHAN
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/09/1991
Decision Date 11/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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