The following data is part of a premarket notification filed by Sweet Micro Systems, Inc. with the FDA for Accutek Periodontal Probe.
| Device ID | K880827 |
| 510k Number | K880827 |
| Device Name: | ACCUTEK PERIODONTAL PROBE |
| Classification | Probe, Periodontic |
| Applicant | SWEET MICRO SYSTEMS, INC. 50 FREEWAY DR. Cranston, RI 02920 |
| Contact | Nicholas H Kondon |
| Correspondent | Nicholas H Kondon SWEET MICRO SYSTEMS, INC. 50 FREEWAY DR. Cranston, RI 02920 |
| Product Code | EIX |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-01 |
| Decision Date | 1988-04-12 |