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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 K060273
Device Name SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837
Applicant
SLEEPNET CORPORATION
1050 PERIMETER RD.
MANCHESTER AIR CENTER
MANCHESTER,  NH  03103
Applicant Contact PAUL CHIESA
Correspondent
SLEEPNET CORPORATION
1050 PERIMETER RD.
MANCHESTER AIR CENTER
MANCHESTER,  NH  03103
Correspondent Contact PAUL CHIESA
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/02/2006
Decision Date 05/02/2006
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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