The following data is part of a premarket notification filed by Dr. Micheal A. Sabia with the FDA for Scolimeter.
| Device ID | K831898 |
| 510k Number | K831898 |
| Device Name: | SCOLIMETER |
| Classification | Caliper |
| Applicant | DR. MICHEAL A. SABIA 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | KTZ |
| CFR Regulation Number | 888.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-14 |
| Decision Date | 1983-07-19 |