SPIRALE DRUG DELIVERY SYSTEM


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K111246
Device Name SPIRALE DRUG DELIVERY SYSTEM
Applicant
ARMSTRONG MEDICAL LTD.
wattstown business park
newbridge rd.
coleraine, 

IE

bt52 1bs

Applicant Contact ian stewart
Correspondent
ARMSTRONG MEDICAL LTD.
wattstown business park
newbridge rd.
coleraine, 

IE

bt52 1bs

Correspodent Contact ian stewart
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 05/04/2011
Decision Date 08/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No