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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 K100705
Device Name ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
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 Received03/12/2010
Decision Date 07/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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