The following data is part of a premarket notification filed by Smith & Nephew, Mpl Division with the FDA for Max-i-probe Periodontal Endodontic Prob.
| Device ID | K840237 |
| 510k Number | K840237 |
| Device Name: | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB |
| Classification | Syringe, Periodontic, Endodontic, Irrigating |
| Applicant | SMITH & NEPHEW, MPL DIVISION 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EIC |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-20 |
| Decision Date | 1984-04-05 |