The following data is part of a premarket notification filed by Accurate Surgical Instruments Co. with the FDA for Catheter Bubble Stand.
| Device ID | K813487 |
| 510k Number | K813487 |
| Device Name: | CATHETER BUBBLE STAND |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | ACCURATE SURGICAL INSTRUMENTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-01 |
| Decision Date | 1981-12-31 |