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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 K003249
Device Name PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228
Applicant
PST, INC.
2462 EMBARCADERO WAY
PALO ALTO,  CA  94303
Applicant Contact WILLIAM NADEL
Correspondent
PST, INC.
2462 EMBARCADERO WAY
PALO ALTO,  CA  94303
Correspondent Contact WILLIAM NADEL
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/17/2000
Decision Date 12/12/2000
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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