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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, infusion
510(k) Number K071545
Device Name Z-800 VOLUMETRIC INFUSION PUMP
Applicant
ZYNO MEDICAL LLC
395 TOTTEN POND RD. SUITE 201
waltham,  MA  02451
Applicant Contact chaoyoung lee
Correspondent
ZYNO MEDICAL LLC
395 TOTTEN POND RD. SUITE 201
waltham,  MA  02451
Correspondent Contact chaoyoung lee
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/06/2007
Decision Date 10/31/2007
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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