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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 K931603
Device Name MILLIPORE RT-100 AEROSOL RETENTION FILTER
Applicant
STERIMATICS CO.
PATRIOTS PARK
BEDFORD,  MA  01730
Applicant Contact THOMAS BORROWS
Correspondent
STERIMATICS CO.
PATRIOTS PARK
BEDFORD,  MA  01730
Correspondent Contact THOMAS BORROWS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/01/1993
Decision Date 05/13/1993
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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