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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Ophthalmic
510(k) Number K852633
Device Name VERSABLADE
Applicant
Alphamedix, Inc.
10907 Northridge Sq.
Cupertino,  CA  95014
Applicant Contact CARL R JORDAN
Correspondent
Alphamedix, Inc.
10907 Northridge Sq.
Cupertino,  CA  95014
Correspondent Contact CARL R JORDAN
Regulation Number886.4350
Classification Product Code
HNN  
Date Received06/20/1985
Decision Date 11/04/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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