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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
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