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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 K103434
Device Name 3B FLEX-LITE
Applicant
3B Products, LLC
1142 N Scenic Hwy.
Lake Wales,  FL  33853
Applicant Contact ALBERT ALEXANDER LUCIO
Correspondent
3B Products, LLC
1142 N Scenic Hwy.
Lake Wales,  FL  33853
Correspondent Contact ALBERT ALEXANDER LUCIO
Regulation Number868.5905
Classification Product Code
BZD  
Date Received11/23/2010
Decision Date 10/13/2011
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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