The following data is part of a premarket notification filed by Valley Forge Scientific Corp. with the FDA for Valley Forge Bipolar Ball Tip Electrode.
| Device ID | K973554 |
| 510k Number | K973554 |
| Device Name: | VALLEY FORGE BIPOLAR BALL TIP ELECTRODE |
| Classification | Electrode, Electrosurgical |
| Applicant | VALLEY FORGE SCIENTIFIC CORP. 136 GREEN TREE RD. P.O. BOX 1179 Oaks, PA 19456 |
| Contact | Jerry L Malis |
| Correspondent | Jerry L Malis VALLEY FORGE SCIENTIFIC CORP. 136 GREEN TREE RD. P.O. BOX 1179 Oaks, PA 19456 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-19 |
| Decision Date | 1997-12-19 |
| Summary: | summary |