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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory To Continuous Ventilator (Respirator)
510(k) Number K040712
Device Name AIR SAFETY HEPA, MODEL 3500
Applicant
Air Safety, Ltd.
6329 W.Waterview Ct.
Mccordsville,  IN  46055 -9501
Applicant Contact PAUL DRYDEN
Correspondent
Air Safety, Ltd.
6329 W.Waterview Ct.
Mccordsville,  IN  46055 -9501
Correspondent Contact PAUL DRYDEN
Regulation Number868.5895
Classification Product Code
MOD  
Date Received03/18/2004
Decision Date 06/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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