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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K841718
Device Name FREKATHETER VENOUS CATHETERISATION SYS
Applicant
Fresenius USA, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Fresenius USA, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received04/25/1984
Decision Date 04/25/1984
Decision SE - Postmarket Surveillance Required (SESP)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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