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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 K203601
Device Name Innova Nasal Non-Vented Mask
Applicant
Sleepnet Corporation
5 Merrill Industrial Dr.
Hampton,  NH  03842
Applicant Contact Jennifer Kennedy
Correspondent
Sleepnet Corporation % Promedic, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/09/2020
Decision Date 04/30/2021
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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