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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, And Accessories, Dental
510(k) Number K000768
Device Name WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
Applicant
Wallach Surgical Devices, Inc.
235 Edison Rd.
Orange,  CT  06477
Applicant Contact MICHAEL MALIS
Correspondent
Wallach Surgical Devices, Inc.
235 Edison Rd.
Orange,  CT  06477
Correspondent Contact MICHAEL MALIS
Regulation Number872.4920
Classification Product Code
EKZ  
Date Received03/09/2000
Decision Date 04/11/2000
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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