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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Non-Electrical
510(k) Number K932408
Device Name AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS
Applicant
Baxter Healthcare Corp
Route 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact PATRICIA S BARSANTI
Correspondent
Baxter Healthcare Corp
Route 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact PATRICIA S BARSANTI
Regulation Number876.4730
Classification Product Code
FFN  
Date Received05/18/1993
Decision Date 09/28/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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