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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 K991591
Device Name BIOTHANE PATIENT RESTRAINT
Applicant
Bioplastics
34655 Mills Rd.
N. Ridgeville,  OH  44039
Applicant Contact CLAIRE BORON
Correspondent
Bioplastics
34655 Mills Rd.
N. Ridgeville,  OH  44039
Correspondent Contact CLAIRE BORON
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received05/07/1999
Decision Date 07/29/1999
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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