MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K111570
Device Name MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
Applicant
THAYER MEDICAL CORPORATION
4575 south palo verde road
suite 337
tucson, 
AZ 
85714 -1961

Applicant Contact erika s strickland
Correspondent
THAYER MEDICAL CORPORATION
4575 south palo verde road
suite 337
tucson, 
AZ 
85714 -1961

Correspodent Contact erika s strickland
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 06/06/2011
Decision Date 09/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No