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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 K233415
Device Name DELTAWAVE Nasal Pillows System
Applicant
Remsleep Holdings
14175 Icot Blvd.
Clearwater,  FL  33760
Applicant Contact Tom Wood
Correspondent
Strzepek Consulting
18111 Littleton Pl.
Lakewood Ranch,  FL  34202
Correspondent Contact Judy Strzepek
Regulation Number868.5905
Classification Product Code
BZD  
Date Received10/10/2023
Decision Date 07/02/2024
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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