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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K944429
Device Name PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING
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 Number868.5240
Classification Product Code
CAI  
Date Received09/12/1994
Decision Date 11/18/1994
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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