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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Gas-Scavenging
510(k) Number K160950
Device Name MINISCAV
Applicant
Sedation Systems, LLC
2471 Mcmullen Booth Rd. Suite 316
Clearwater,  FL  33759
Applicant Contact S. Michael Bender
Correspondent
Sedation Systems, LLC
2471 Mcmullen Booth Rd. Suite 316
Clearwater,  FL  33759
Correspondent Contact Paul Dryden
Regulation Number868.5430
Classification Product Code
CBN  
Subsequent Product Code
BTA  
Date Received04/05/2016
Decision Date 05/05/2017
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
Recalls CDRH Recalls
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