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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 K935036
Device Name HEPA FILTERED HEAT AND MOISTURE EXCHANGER
Applicant
Intertech Resources, Inc.
5100 Tice St.
Fort Myers,  FL  33905
Applicant Contact Lee Leichter
Correspondent
Intertech Resources, Inc.
5100 Tice St.
Fort Myers,  FL  33905
Correspondent Contact Lee Leichter
Regulation Number868.5375
Classification Product Code
BYD  
Date Received09/29/1993
Decision Date 01/25/1994
Decision Substantially Equivalent - Kit (SESK)
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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