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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 K082786
Device Name PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES
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 Received09/23/2008
Decision Date 12/03/2008
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
Recalls CDRH Recalls
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