The following data is part of a premarket notification filed by Custom Medical Products, Ltd. with the FDA for Arthroscopic Leg Holder 434-21.
| Device ID | K834076 |
| 510k Number | K834076 |
| Device Name: | ARTHROSCOPIC LEG HOLDER 434-21 |
| Classification | Arthroscope |
| Applicant | CUSTOM MEDICAL PRODUCTS, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-25 |
| Decision Date | 1983-12-27 |