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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 K896923
Device Name INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT
Applicant
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS,  FL  33905
Applicant Contact JAMES POPE
Correspondent
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS,  FL  33905
Correspondent Contact JAMES POPE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/12/1989
Decision Date 03/12/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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