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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K880637
Device Name BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
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 Number868.5975
Classification Product Code
BZO  
Date Received02/16/1988
Decision Date 04/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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