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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 K910637
Device Name MENTOR(R) SUR-E-TROL(R)
Applicant
Mentor O & O, Inc.
3000 Longwater Dr.
Norwell,  MA  02061
Applicant Contact RICHARD L FOLLETT
Correspondent
Mentor O & O, Inc.
3000 Longwater Dr.
Norwell,  MA  02061
Correspondent Contact RICHARD L FOLLETT
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/13/1991
Decision Date 05/13/1991
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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