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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Protective
510(k) Number K971561
Device Name PROVEST-PROTECTIVE RESTRAINT
Applicant
Jemm Medical Products
42909 Alep St.
Lancaster,  CA  93536
Applicant Contact ANGELITA KOWALEWSKY
Correspondent
Jemm Medical Products
42909 Alep St.
Lancaster,  CA  93536
Correspondent Contact ANGELITA KOWALEWSKY
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received04/29/1997
Decision Date 07/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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