510(k) K943874
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