The following data is part of a premarket notification filed by D.l. Nelson And Assoc., Inc. with the FDA for Tko Telescoping Lithotomy Stirrup.
| Device ID | K904826 |
| 510k Number | K904826 |
| Device Name: | TKO TELESCOPING LITHOTOMY STIRRUP |
| Classification | Operating Room Accessories Table Tray |
| Applicant | D.L. NELSON AND ASSOC., INC. 2902 MARLIN CIR. Atlanta, GA 30341 -5118 |
| Contact | Dennis L Nelson |
| Correspondent | Dennis L Nelson D.L. NELSON AND ASSOC., INC. 2902 MARLIN CIR. Atlanta, GA 30341 -5118 |
| Product Code | FWZ |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-25 |
| Decision Date | 1990-10-31 |