The following data is part of a premarket notification filed by Precision Thermoplastic Components, Inc. with the FDA for Precison Thermoplastic Components Gas Ampling Lines And Connectors.
| Device ID | K943874 |
| 510k Number | K943874 |
| Device Name: | PRECISON THERMOPLASTIC COMPONENTS GAS AMPLING LINES AND CONNECTORS |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | PRECISION THERMOPLASTIC COMPONENTS, INC. 1025 FINDLAY RD. P.O. BOX 1296 Lima, OH 45802 |
| Contact | Sarah Woessner |
| Correspondent | Sarah Woessner PRECISION THERMOPLASTIC COMPONENTS, INC. 1025 FINDLAY RD. P.O. BOX 1296 Lima, OH 45802 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-08 |
| Decision Date | 1994-10-28 |