The following data is part of a premarket notification filed by Precise Optics with the FDA for Precision Intra-oral Scopes.
| Device ID | K932878 |
| 510k Number | K932878 |
| Device Name: | PRECISION INTRA-ORAL SCOPES |
| Classification | Unit, Operative Dental |
| Applicant | PRECISE OPTICS 22 EAST BROADWAY Gardner, MA 01440 |
| Contact | James A Reilly |
| Correspondent | James A Reilly PRECISE OPTICS 22 EAST BROADWAY Gardner, MA 01440 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-14 |
| Decision Date | 1994-01-06 |