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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Orbital, Extra-Ocular
510(k) Number K983581
Device Name OCU-GUARD AND OCU-GUARD SUPPLE
Applicant
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114
Applicant Contact DIANNA L GECK
Correspondent
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114
Correspondent Contact DIANNA L GECK
Regulation Number886.3340
Classification Product Code
HQX  
Date Received10/13/1998
Decision Date 11/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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