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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 K931480
Device Name CLEANBLADE
Applicant
Cleanblade, Inc.
18375 Bernardo Trl.s Ct.
San Diego,  CA  92128
Applicant Contact DENNIS LEAHY
Correspondent
Cleanblade, Inc.
18375 Bernardo Trl.s Ct.
San Diego,  CA  92128
Correspondent Contact DENNIS LEAHY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/24/1993
Decision Date 07/23/1993
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
Predetermined Change
Control Plan Authorized		 No
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