56 SERIES JET NEBULIZER


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K021443
Device Name 56 SERIES JET NEBULIZER
Original Applicant
PROJECT MARKETING
112 caviston way
cary, 
NC 
27560

Original Contact terry o’brien
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 05/06/2002
Decision Date 10/21/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No