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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Circumcision
510(k) Number K884290
Device Name BAXTER DISPOSABLE CIRCUMCISION TRAY
Applicant
Baxter Healthcare Corp
7280 N. Caldwell
Niles,  IL  60648
Applicant Contact MORIZIO, R.N.
Correspondent
Baxter Healthcare Corp
7280 N. Caldwell
Niles,  IL  60648
Correspondent Contact MORIZIO, R.N.
Regulation Number884.4530
Classification Product Code
HFX  
Date Received10/12/1988
Decision Date 12/08/1988
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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