510(k) K943874

PRECISON THERMOPLASTIC COMPONENTS GAS AMPLING LINES AND CONNECTORS by Precision Thermoplastic Components, Inc. — Product Code CAH

K943874 is an FDA 510(k) premarket notification submitted by Precision Thermoplastic Components, Inc. for the device "PRECISON THERMOPLASTIC COMPONENTS GAS AMPLING LINES AND CONNECTORS". The FDA issued a decision of Substantially Equivalent on October 28, 1994. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Precision Thermoplastic Components, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1994
Date Received
August 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type