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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, elastomeric
510(k) Number K913658
Device Name IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD
Applicant
IMED CORP.
9775 BUSINESSPARK AVE.
SAN DIEGO,  CA  92131 -1699
Applicant Contact RALPH H JARBOE
Correspondent
IMED CORP.
9775 BUSINESSPARK AVE.
SAN DIEGO,  CA  92131 -1699
Correspondent Contact RALPH H JARBOE
Regulation Number880.5725
Classification Product Code
MEB  
Date Received07/29/1991
Decision Date 03/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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