The following data is part of a premarket notification filed by Valley Forge Scientific Corp. with the FDA for Malis Cmc-ii Bipolar Coagulator & Cut.
| Device ID | K831508 |
| 510k Number | K831508 |
| Device Name: | MALIS CMC-II BIPOLAR COAGULATOR & CUT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEY FORGE SCIENTIFIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-11 |
| Decision Date | 1983-06-24 |