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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Abduction, Congenital Hip Dislocation
510(k) Number K780375
Device Name PAVLIK HARNESS
Applicant
BIOMET, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOMET, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number890.3665
Classification Product Code
IOZ  
Date Received03/08/1978
Decision Date 03/15/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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