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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 K842324
Device Name PERFOURM
Applicant
Cutter Laboratories, Inc.
P.O. Box 1986
Berkeley,  CA  94701
Applicant Contact STEVEN OJALA
Correspondent
Cutter Laboratories, Inc.
P.O. Box 1986
Berkeley,  CA  94701
Correspondent Contact STEVEN OJALA
Regulation Number872.3660
Classification Product Code
ELW  
Date Received06/13/1984
Decision Date 11/09/1984
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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