The following data is part of a premarket notification filed by Valley Forge Scientific Corp. with the FDA for Malis Surgical Mesh For Skull /spinal Column Repai.
| Device ID | K861822 |
| 510k Number | K861822 |
| Device Name: | MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | VALLEY FORGE SCIENTIFIC CORP. P.O. BOX 925 Valley Forge, PA 19482 |
| Contact | Jerry Malis |
| Correspondent | Jerry Malis VALLEY FORGE SCIENTIFIC CORP. P.O. BOX 925 Valley Forge, PA 19482 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-12 |
| Decision Date | 1986-07-11 |