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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K854106
Device Name BAYSILEX
Applicant
Cutter Laboratories, Inc.
Fourth And Parker St.S
Box 1986
Berkeley,  CA  94710
Applicant Contact STEVEN J OJALA
Correspondent
Cutter Laboratories, Inc.
Fourth And Parker St.S
Box 1986
Berkeley,  CA  94710
Correspondent Contact STEVEN J OJALA
Regulation Number872.3660
Classification Product Code
ELW  
Date Received10/08/1985
Decision Date 03/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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