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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K063806
Device Name SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED
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 Number868.5895
Classification Product Code
CBK  
Date Received12/22/2006
Decision Date 05/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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