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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name conserver, oxygen
510(k) Number K961126
Device Name PULSE DOSE SERIES
Applicant
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET,  PA  15501 -0635
Applicant Contact GREGORY W GOOD
Correspondent
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET,  PA  15501 -0635
Correspondent Contact GREGORY W GOOD
Regulation Number868.5905
Classification Product Code
NFB  
Date Received03/21/1996
Decision Date 10/21/1996
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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