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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 K954194
Device Name DISPOSABLE HME/FILTER
Applicant
ENGSTROM MEDICAL
67920 KLINGER LAKE RD.
STURGIS,  MI  49091 -9288
Applicant Contact PAUL E DRYDEN
Correspondent
ENGSTROM MEDICAL
67920 KLINGER LAKE RD.
STURGIS,  MI  49091 -9288
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5375
Classification Product Code
BYD  
Date Received09/06/1995
Decision Date 10/20/1995
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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