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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Corkscrew
510(k) Number K875166
Device Name PHARMASEAL STERILE UMBILICAL CORD CLAMP
Applicant
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355 -8900
Applicant Contact W GETLIN
Correspondent
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355 -8900
Correspondent Contact W GETLIN
Regulation Number888.4540
Classification Product Code
HWI  
Date Received12/17/1987
Decision Date 03/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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