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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Diamond, Dental
510(k) Number K943841
Device Name SOPHOS DENTAL DIAMOND
Applicant
Sophos Technologic
2802 Riachuelo Cir.
San Clemente,  CA  92673
Applicant Contact DANIEL W LOYER
Correspondent
Sophos Technologic
2802 Riachuelo Cir.
San Clemente,  CA  92673
Correspondent Contact DANIEL W LOYER
Regulation Number872.4535
Classification Product Code
DZP  
Date Received08/05/1994
Decision Date 09/16/1994
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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