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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cover, barrier, protective
510(k) Number K962288
Device Name COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
Applicant
PINNACLE PRODUCTS, INC.
624 SOUTH SMITH AVE.
ST. PAUL,  MN  55107
Applicant Contact THOMAS LASING
Correspondent
PINNACLE PRODUCTS, INC.
624 SOUTH SMITH AVE.
ST. PAUL,  MN  55107
Correspondent Contact THOMAS LASING
Regulation Number878.4370
Classification Product Code
MMP  
Date Received06/14/1996
Decision Date 01/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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