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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K071575
Device Name SANDMAN INTRO
Applicant
Mallinckrodt Developpement France
4280 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact JAMES BONDS
Correspondent
Mallinckrodt Developpement France
4280 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact JAMES BONDS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/08/2007
Decision Date 09/10/2007
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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