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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name warmer, thermal, infusion fluid
510(k) Number K121198
Device Name BW685, BW685S
Original Applicant
24301 woodsage dr
bonita springs,  FL  34134
Original Contact paul dryden
Classification Product Code
Date Received04/19/2012
Decision Date 07/12/2012
Decision substantially equivalent (SESE)
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No