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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Condenser, Heat And Moisture (Artificial Nose)
510(k) Number K934190
Device Name HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION
Applicant
BIRD LIFE DESIGN
4450 ALPHA RD.
DALLAS,  TX  75244 -4505
Applicant Contact EBECCA D FULLER
Correspondent
BIRD LIFE DESIGN
4450 ALPHA RD.
DALLAS,  TX  75244 -4505
Correspondent Contact EBECCA D FULLER
Regulation Number868.5375
Classification Product Code
BYD  
Date Received08/26/1993
Decision Date 11/24/1993
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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