The following data is part of a premarket notification filed by Valley Forge Scientific Corp. with the FDA for Stryker Interventional Pain Rf Generator.
| Device ID | K032601 |
| 510k Number | K032601 |
| Device Name: | STRYKER INTERVENTIONAL PAIN RF GENERATOR |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | VALLEY FORGE SCIENTIFIC CORP. 136 GREEN TREE RD. Oaks, PA 19456 |
| Contact | Jerry Malis |
| Correspondent | Jerry Malis VALLEY FORGE SCIENTIFIC CORP. 136 GREEN TREE RD. Oaks, PA 19456 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-25 |
| Decision Date | 2004-04-01 |
| Summary: | summary |