The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Spectron Conversion Endoprosthesis Cup.
| Device ID | K823726 |
| 510k Number | K823726 |
| Device Name: | SPECTRON CONVERSION ENDOPROSTHESIS CUP |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-10 |
| Decision Date | 1983-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010079527 | K823726 | 000 |
| 03596010079190 | K823726 | 000 |
| 03596010079183 | K823726 | 000 |
| 03596010079176 | K823726 | 000 |
| 03596010079169 | K823726 | 000 |
| 03596010411853 | K823726 | 000 |
| 03596010409294 | K823726 | 000 |
| 03596010306869 | K823726 | 000 |
| 03596010306852 | K823726 | 000 |
| 03596010306838 | K823726 | 000 |
| 03596010196514 | K823726 | 000 |
| 03596010196507 | K823726 | 000 |
| 03596010196477 | K823726 | 000 |
| 03596010196460 | K823726 | 000 |
| 03596010196453 | K823726 | 000 |
| 03596010196446 | K823726 | 000 |
| 03596010079206 | K823726 | 000 |
| 03596010079350 | K823726 | 000 |
| 03596010079367 | K823726 | 000 |
| 03596010079510 | K823726 | 000 |
| 03596010079503 | K823726 | 000 |
| 03596010079497 | K823726 | 000 |
| 03596010079480 | K823726 | 000 |
| 03596010079473 | K823726 | 000 |
| 03596010079466 | K823726 | 000 |
| 03596010079459 | K823726 | 000 |
| 03596010079442 | K823726 | 000 |
| 03596010079435 | K823726 | 000 |
| 03596010079428 | K823726 | 000 |
| 03596010079411 | K823726 | 000 |
| 03596010079404 | K823726 | 000 |
| 03596010079398 | K823726 | 000 |
| 03596010079381 | K823726 | 000 |
| 03596010079374 | K823726 | 000 |
| 03596010196415 | K823726 | 000 |