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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Ophthalmic
510(k) Number K915074
Device Name IRRIGATOR/ASPIRATOR PROBE
Applicant
Biomedical Dynamics, Inc.
12250 Nicollet Ave.
Burnsville,  MN  55337
Applicant Contact JOHN MOBERG
Correspondent
Biomedical Dynamics, Inc.
12250 Nicollet Ave.
Burnsville,  MN  55337
Correspondent Contact JOHN MOBERG
Regulation Number886.4350
Classification Product Code
HMX  
Date Received11/08/1991
Decision Date 02/05/1992
Decision Substantially Equivalent (SESE)
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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