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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 K912335
Device Name ARTEMA AQUA+ N
Applicant
ARTEMA MEDICAL AB
RISSNELEDEN 136
S-172 48 SUNDYBERG
SWEDEN,  SE
Applicant Contact CARL HAMILTON
Correspondent
ARTEMA MEDICAL AB
RISSNELEDEN 136
S-172 48 SUNDYBERG
SWEDEN,  SE
Correspondent Contact CARL HAMILTON
Regulation Number868.5375
Classification Product Code
BYD  
Date Received05/24/1991
Decision Date 07/26/1991
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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