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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 K812035
Device Name IMED ACCUSET CASSETTE
Applicant
IMED CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
IMED CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/20/1981
Decision Date 07/28/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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