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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 HIGHWAY
LAKE WALES,  FL  33853
Applicant Contact ALBERT ALEXANDER LUCIO
Correspondent
3B PRODUCTS, LLC
1142 N SCENIC HIGHWAY
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
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