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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 K112271
Device Name 3B WILLOW
Applicant
3B PRODUCTS, LLC
1142 N SCENIC HIGHWAY
LAKE WALES,  FL  33853
Applicant Contact ALEX LUCIO
Correspondent
3B PRODUCTS, LLC
1142 N SCENIC HIGHWAY
LAKE WALES,  FL  33853
Correspondent Contact ALEX LUCIO
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/08/2011
Decision Date 02/16/2012
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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