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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
Applicant Contact PAUL E DRYDEN
Correspondent
Engstrom Medical
67920 Klinger Lake Rd.
Sturgis,  MI  49091
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
Predetermined Change
Control Plan Authorized		 No
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