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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact ERIKA S STRICKLAND
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/06/2011
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
Recalls CDRH Recalls
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