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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Lift, Patient, Ac-Powered
510(k) Number K905414
Device Name MANGAR BOOSTER
Applicant
Northfleet Management Group, Inc.
The Manor House
2 Hayden Rowe
Hopkinton,  MA  01748
Applicant Contact MICHAEL L BARRETTI
Correspondent
Northfleet Management Group, Inc.
The Manor House
2 Hayden Rowe
Hopkinton,  MA  01748
Correspondent Contact MICHAEL L BARRETTI
Regulation Number880.5500
Classification Product Code
FNG  
Date Received12/03/1990
Decision Date 03/05/1991
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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