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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K850544
Device Name SHAVE PREP TRAY
Applicant
Packaging Technologies, Inc.
262 Gemini Ave.
Brea,  CA  92621
Applicant Contact ROBERT W FAIR
Correspondent
Packaging Technologies, Inc.
262 Gemini Ave.
Brea,  CA  92621
Correspondent Contact ROBERT W FAIR
Regulation Number880.6060
Classification Product Code
KME  
Date Received02/12/1985
Decision Date 03/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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