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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 K061829
Device Name ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
Applicant
New Leaf Medical, Inc.
11476 Hawke Rd.
Suite #C
Columbia Station,  OH  44028
Applicant Contact RICHARD T NOCK
Correspondent
New Leaf Medical, Inc.
11476 Hawke Rd.
Suite #C
Columbia Station,  OH  44028
Correspondent Contact RICHARD T NOCK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/28/2006
Decision Date 11/17/2006
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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