The following data is part of a premarket notification filed by Artec Environmental Monitoring Division with the FDA for Artec Twist Valve.
| Device ID | K830056 |
| 510k Number | K830056 |
| Device Name: | ARTEC TWIST VALVE |
| Classification | Bag, Reservoir |
| Applicant | ARTEC ENVIRONMENTAL MONITORING DIVISION 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTC |
| CFR Regulation Number | 868.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-06 |
| Decision Date | 1983-03-09 |