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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K961791
Device Name DEPUY DISPOSABLE FILTER/HOOD
Applicant
DEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46581 -0988
Applicant Contact CHERYL HASTINGS
Correspondent
DEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46581 -0988
Correspondent Contact CHERYL HASTINGS
Regulation Number878.4040
Classification Product Code
LYU  
Date Received05/09/1996
Decision Date 08/09/1996
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
Predetermined Change
Control Plan Authorized		 No
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