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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Electrosurgical
510(k) Number K911353
Device Name EMC MODEL NO. STATOME 900
Applicant
Emc Industries
C/O Philip R. Hardaker & Assoc
1689 Middleton Ave.
Los Altos,  CA  94024
Applicant Contact PHILIP R HARDAKER
Correspondent
Emc Industries
C/O Philip R. Hardaker & Assoc
1689 Middleton Ave.
Los Altos,  CA  94024
Correspondent Contact PHILIP R HARDAKER
Regulation Number878.4400
Classification Product Code
HAM  
Date Received03/27/1991
Decision Date 06/24/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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