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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K934509
Device Name PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER
Applicant
Sdi Diagnostics, Inc.
Shovel Shop Sq.
Bldg. 11
North Easton,  MA  02356
Applicant Contact MICHAEL J BOYLE
Correspondent
Sdi Diagnostics, Inc.
Shovel Shop Sq.
Bldg. 11
North Easton,  MA  02356
Correspondent Contact MICHAEL J BOYLE
Regulation Number868.5260
Classification Product Code
CAH  
Date Received09/14/1993
Decision Date 10/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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