NEB-U-MASK SYSTEM, MODELS 1895, 1896


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K080230
Device Name NEB-U-MASK SYSTEM, MODELS 1895, 1896
Applicant
Teleflex Medical, Inc.
24301 woodsage dr
bonita springs, 
FL 
34134 -2015

Applicant Contact paul dryden
Correspondent
Teleflex Medical, Inc.
24301 woodsage dr
bonita springs, 
FL 
34134 -2015

Correspodent Contact paul dryden
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 01/30/2008
Decision Date 06/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No