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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Bite
510(k) Number K770090
Device Name BLACHLY BITE BLOK & CHEEK FILLER
Applicant
P.H. Blachly, M.D.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
P.H. Blachly, M.D.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.5070
Classification Product Code
JXL  
Date Received01/17/1977
Decision Date 01/31/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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