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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K962161
Device Name BAXTER NEBULIZER CAP MODEL 2D0868
Applicant
BAXTER HEALTHCARE CORP.
40178 U.S. 19 NORTH
TARPON SPRINGS,  FL  34689
Applicant Contact ED RANSOM
Correspondent
BAXTER HEALTHCARE CORP.
40178 U.S. 19 NORTH
TARPON SPRINGS,  FL  34689
Correspondent Contact ED RANSOM
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/04/1996
Decision Date 08/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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