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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 K102029
Device Name PEAK PULSAR II GENERATOR MODEL PS100-102
Applicant
Peak Surgical, Inc.
2464 Embarcadero Way
Palo Alto,  CA  94303
Applicant Contact LOIS NAKAYAMA
Correspondent
Peak Surgical, Inc.
2464 Embarcadero Way
Palo Alto,  CA  94303
Correspondent Contact LOIS NAKAYAMA
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/19/2010
Decision Date 12/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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