The following data is part of a premarket notification filed by Jerome M. Simon with the FDA for Accu-bite Home Kit Discluder.
| Device ID | K980953 |
| 510k Number | K980953 |
| Device Name: | ACCU-BITE HOME KIT DISCLUDER |
| Classification | Mouthguard, Prescription |
| Applicant | JEROME M. SIMON 1500 SUMMER ST. Stamford, CT 06905 |
| Contact | Jerome M Simon |
| Correspondent | Jerome M Simon JEROME M. SIMON 1500 SUMMER ST. Stamford, CT 06905 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-13 |
| Decision Date | 1998-10-07 |