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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Surgical
510(k) Number K080133
Device Name MOUNTABLE ENDOSCOPIC BLADE
Applicant
A.M. Surgical, Inc.
290 E. Main St.
Suite 200
Smithtown,  NY  11787
Applicant Contact VINCENT PASCALE
Correspondent
A.M. Surgical, Inc.
290 E. Main St.
Suite 200
Smithtown,  NY  11787
Correspondent Contact VINCENT PASCALE
Regulation Number878.4800
Classification Product Code
EMF  
Date Received01/18/2008
Decision Date 03/13/2008
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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