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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name compressor, air, portable
510(k) Number K883704
Device Name MULTIICHALLENGE NEBULIZER SYSTEM
Applicant
BIOTRINE CORP.
52 DRAGON CT
WOBURN,  MA  01801
Applicant Contact BURKE, JR.
Correspondent
BIOTRINE CORP.
52 DRAGON CT
WOBURN,  MA  01801
Correspondent Contact BURKE, JR.
Regulation Number868.6250
Classification Product Code
BTI  
Date Received08/30/1988
Decision Date 11/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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