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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 K101857
Device Name RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
Applicant
INSTRUMENTATION INDUSTRIES, INC.
2990 INDUSTRIAL BLVD.
BETHEL PARK,  PA  15102
Applicant Contact DORIS F WALTER
Correspondent
INSTRUMENTATION INDUSTRIES, INC.
2990 INDUSTRIAL BLVD.
BETHEL PARK,  PA  15102
Correspondent Contact DORIS F WALTER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/02/2010
Decision Date 07/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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