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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K894936
Device Name PROTOLOGIC MODEL SER-1
Applicant
Protologic, Inc.
Rfd 5 Box 194
Cornhill At Dearmeadow
Webster,  NH  03303
Applicant Contact STEPHEN MACGREGOR
Correspondent
Protologic, Inc.
Rfd 5 Box 194
Cornhill At Dearmeadow
Webster,  NH  03303
Correspondent Contact STEPHEN MACGREGOR
Regulation Number868.5270
Classification Product Code
BZE  
Date Received08/03/1989
Decision Date 01/22/1990
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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