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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K000245
Device Name CSM STRETTA SYSTEM
Applicant
CONWAY STUART MEDICAL, INC.
555 THIRTEENTH ST. N.W.
washington,  DC  20004 -1109
Applicant Contact jonathan s kahan
Correspondent
CONWAY STUART MEDICAL, INC.
555 THIRTEENTH ST. N.W.
washington,  DC  20004 -1109
Correspondent Contact jonathan s kahan
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/27/2000
Decision Date 04/18/2000
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
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