The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Lithotomy Chair #415.
| Device ID | K831385 |
| 510k Number | K831385 |
| Device Name: | LITHOTOMY CHAIR #415 |
| Classification | Chair, Surgical, Ac-powered |
| Applicant | MIDMARK CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GBB |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-28 |
| Decision Date | 1983-06-02 |