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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 K780232
Device Name RESTRAINT, PROTECTIVE
Applicant
Biomet, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Biomet, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received02/09/1978
Decision Date 02/21/1978
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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