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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 K893875
Device Name FLOCARE
Applicant
Mega-Tech Intl., Inc.
175 Strafford Ave.
Wayne,  PA  19087
Applicant Contact AL W KRAUS
Correspondent
Mega-Tech Intl., Inc.
175 Strafford Ave.
Wayne,  PA  19087
Correspondent Contact AL W KRAUS
Regulation Number868.5375
Classification Product Code
BYD  
Date Received05/26/1989
Decision Date 08/11/1989
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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