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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 K121692
Device Name MINIME 2 NASAL MASK
Applicant
Sleepnet Corporation
24301 Woodsage Dr.
Bonita Springs,  FL  34134 -2958
Applicant Contact PAUL DRYDEN
Correspondent
Sleepnet Corporation
24301 Woodsage Dr.
Bonita Springs,  FL  34134 -2958
Correspondent Contact PAUL DRYDEN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/07/2012
Decision Date 11/05/2012
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
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