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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 K964779
Device Name MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE
Applicant
Quantum Loop, Inc.
2479 Alameda De Las Pulgas
Redwood City,  CA  94061
Applicant Contact THOMAS C WEHMAN
Correspondent
Quantum Loop, Inc.
2479 Alameda De Las Pulgas
Redwood City,  CA  94061
Correspondent Contact THOMAS C WEHMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/27/1996
Decision Date 08/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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