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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 K013306
Device Name MINIME NASAL MASK, MODEL P/N 50220
Applicant
Sleepnet Corporation
1050 Perimeter Rd.,
Lockheed Air Center
Manchester,  NH  03103
Applicant Contact PAUL R CHIESA
Correspondent
Sleepnet Corporation
1050 Perimeter Rd.,
Lockheed Air Center
Manchester,  NH  03103
Correspondent Contact PAUL R CHIESA
Regulation Number868.5905
Classification Product Code
BZD  
Date Received10/04/2001
Decision Date 11/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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