The following data is part of a premarket notification filed by Berkeley Medevices with the FDA for Surgical Loops.
| Device ID | K812389 |
| 510k Number | K812389 |
| Device Name: | SURGICAL LOOPS |
| Classification | Retractor |
| Applicant | BERKELEY MEDEVICES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-20 |
| Decision Date | 1981-11-16 |