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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade, Scalpel
510(k) Number K812160
Device Name MICROSURGICAL BLADE
Applicant
VXTRA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VXTRA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
GES  
Date Received07/29/1981
Decision Date 08/31/1981
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
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