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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hood, Surgical
510(k) Number K902677
Device Name STERI-SHIELD
Applicant
Biomedical Devices, Inc.
1501 E. Chapman, Suite 356
Fullerton,  CA  92631
Applicant Contact NICK HERBERT
Correspondent
Biomedical Devices, Inc.
1501 E. Chapman, Suite 356
Fullerton,  CA  92631
Correspondent Contact NICK HERBERT
Regulation Number878.4040
Classification Product Code
FXY  
Date Received06/18/1990
Decision Date 08/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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