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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 K073057
Device Name PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040
Applicant
Peak Surgical, Inc.
2464 Embarcadero Way
Palo Alto,  CA  94303
Applicant Contact GRACE CARLSON
Correspondent
Peak Surgical, Inc.
2464 Embarcadero Way
Palo Alto,  CA  94303
Correspondent Contact GRACE CARLSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/30/2007
Decision Date 07/22/2008
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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