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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K841104
Device Name ENTERNAL FEEDING PUMP BATTERY OPER.
Applicant
Fresenius USA, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact RAINER K CREMERIUS
Correspondent
Fresenius USA, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact RAINER K CREMERIUS
Date Received03/14/1984
Decision Date 04/30/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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