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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 K862020
Device Name HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER
Applicant
Intertech/Ohio
5030 Tice St.
Fort Myers,  FL  33905
Applicant Contact BLAKE
Correspondent
Intertech/Ohio
5030 Tice St.
Fort Myers,  FL  33905
Correspondent Contact BLAKE
Regulation Number868.5375
Classification Product Code
BYD  
Date Received05/28/1986
Decision Date 06/30/1986
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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