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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Implant, Orbital
510(k) Number K973552
Device Name OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP
Applicant
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114
Applicant Contact JULIE SHERMAN
Correspondent
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114
Correspondent Contact JULIE SHERMAN
Regulation Number886.3320
Classification Product Code
MTZ  
Date Received09/19/1997
Decision Date 12/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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