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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
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