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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K943874
Device Name PRECISON THERMOPLASTIC COMPONENTS GAS AMPLING LINES AND CONNECTORS
Applicant
Precision Thermoplastic Components, Inc.
1025 Findlay Rd.
P.O. Box 1296
Lima,  OH  45802
Applicant Contact SARAH WOESSNER
Correspondent
Precision Thermoplastic Components, Inc.
1025 Findlay Rd.
P.O. Box 1296
Lima,  OH  45802
Correspondent Contact SARAH WOESSNER
Regulation Number868.5260
Classification Product Code
CAH  
Date Received08/08/1994
Decision Date 10/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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