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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement Obturator
510(k) Number K931847
Device Name BIO-PREP CEMENT RESTRICTOR
Applicant
BIO MEDICAL DEVICES, INC.
1752 A LANGLEY AVE.
IRVINE,  CA  92714
Applicant Contact NICK HERBERT
Correspondent
BIO MEDICAL DEVICES, INC.
1752 A LANGLEY AVE.
IRVINE,  CA  92714
Correspondent Contact NICK HERBERT
Regulation Number878.3300
Classification Product Code
LZN  
Date Received04/13/1993
Decision Date 06/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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