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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K980768
Device Name VACUETTE HOLDEX
Applicant
GREINER MEDITECH, INC.
260 GATEWAY DRIVE, SUITE 17A
BEL AIR,  MD  21014
Applicant Contact DOUGLAS L HARRIS
Correspondent
GREINER MEDITECH, INC.
260 GATEWAY DRIVE, SUITE 17A
BEL AIR,  MD  21014
Correspondent Contact DOUGLAS L HARRIS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/27/1998
Decision Date 04/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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