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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Set, Administration, Intravascular
510(k) Number K913076
Device Name I.V. INSTANT TIMER
Applicant
The Master Medical Corp.
C/O Mckenna & Cuneo Law Office
1575 Eye St., NW
Washington,  DC  20005
Applicant Contact DONALD R STONE
Correspondent
The Master Medical Corp.
C/O Mckenna & Cuneo Law Office
1575 Eye St., NW
Washington,  DC  20005
Correspondent Contact DONALD R STONE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/11/1991
Decision Date 10/17/1991
Decision Substantially Equivalent (SESE)
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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