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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Patient
510(k) Number K891820
Device Name DISPOSABLE MEDICAL GOWNS
Applicant
Bioshield, Inc.
2900 Standiford Ave.
Suite 16-B
Modesto,  CA  95350
Applicant Contact JIM JACOBSON
Correspondent
Bioshield, Inc.
2900 Standiford Ave.
Suite 16-B
Modesto,  CA  95350
Correspondent Contact JIM JACOBSON
Regulation Number878.4040
Classification Product Code
FYB  
Date Received03/20/1989
Decision Date 07/24/1989
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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