The following data is part of a premarket notification filed by Bowen & Company, Inc. with the FDA for Cremeen Alveolar Bone Caliper.
| Device ID | K872098 |
| 510k Number | K872098 |
| Device Name: | CREMEEN ALVEOLAR BONE CALIPER |
| Classification | Gauge, Depth, Instrument, Dental |
| Applicant | BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Contact | Susan L Brandt |
| Correspondent | Susan L Brandt BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Product Code | EIL |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-01 |
| Decision Date | 1987-07-31 |