The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Meniscectomy Tray #9715.
| Device ID | K823424 |
| 510k Number | K823424 |
| Device Name: | MENISCECTOMY TRAY #9715 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | CONCEPT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-16 |
| Decision Date | 1983-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10845854030646 | K823424 | 000 |
| 20845854026011 | K823424 | 000 |
| 20845854026004 | K823424 | 000 |
| 10845854017920 | K823424 | 000 |
| 20845854013271 | K823424 | 000 |
| 20845854030643 | K823424 | 000 |
| 20845854017927 | K823424 | 000 |
| 00845854030649 | K823424 | 000 |
| 10845854026083 | K823424 | 000 |
| 10845854026076 | K823424 | 000 |
| 10845854026038 | K823424 | 000 |
| 20845854026028 | K823424 | 000 |
| 20845854026035 | K823424 | 000 |
| 20845854030117 | K823424 | 000 |
| 20845854026158 | K823424 | 000 |
| 20845854026141 | K823424 | 000 |
| 20845854026103 | K823424 | 000 |
| 20845854026097 | K823424 | 000 |
| 20845854026080 | K823424 | 000 |
| 20845854026073 | K823424 | 000 |
| 20845854026066 | K823424 | 000 |
| 20845854026059 | K823424 | 000 |
| 20845854026042 | K823424 | 000 |
| 00845854017923 | K823424 | 000 |