The following data is part of a premarket notification filed by Ormed Mfg., Inc. with the FDA for Round-beehive- Dissectors 3/8.
| Device ID | K831912 |
| 510k Number | K831912 |
| Device Name: | ROUND-BEEHIVE- DISSECTORS 3/8 |
| Classification | Dissector, Surgical, General & Plastic Surgery |
| Applicant | ORMED MFG., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GDI |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-14 |
| Decision Date | 1983-10-31 |