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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 K973190
Device Name ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES
Applicant
Cryomedical Sciences, Inc.
1300 Piccard Dr.
Rockville,  MD  20850
Applicant Contact RICHARD J REINHART
Correspondent
Cryomedical Sciences, Inc.
1300 Piccard Dr.
Rockville,  MD  20850
Correspondent Contact RICHARD J REINHART
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/25/1997
Decision Date 11/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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