SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K113033
Device Name SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
Applicant
NEPHRON PHARMACEUTICALS CORP.
4121 34th st. s.w.
orlando, 
FL 
32811 -6475

Applicant Contact marcus juliano
Correspondent
NEPHRON PHARMACEUTICALS CORP.
4121 34th st. s.w.
orlando, 
FL 
32811 -6475

Correspodent Contact marcus juliano
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 10/12/2011
Decision Date 06/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No