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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bedding, Disposable, Medical
510(k) Number K905003
Device Name BIO-GUARD SHAVE PREP TRAY
Applicant
Network Medical Systems, Inc.
4901 Milwee, #202
Houston,  TX  77092
Applicant Contact SAM HAMOUIE
Correspondent
Network Medical Systems, Inc.
4901 Milwee, #202
Houston,  TX  77092
Correspondent Contact SAM HAMOUIE
Regulation Number880.6060
Classification Product Code
KME  
Date Received11/07/1990
Decision Date 12/28/1990
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
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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