The following data is part of a premarket notification filed by Swiss Precision Mfg. Corp. with the FDA for Prosthetic Restoration Device.
| Device ID | K895283 |
| 510k Number | K895283 |
| Device Name: | PROSTHETIC RESTORATION DEVICE |
| Classification | Pin, Retentive And Splinting, And Accessory Instruments |
| Applicant | SWISS PRECISION MFG. CORP. 66 (E) SOUTH SECOND ST. Bayshore, NY 11706 |
| Contact | Roger K Aletras |
| Correspondent | Roger K Aletras SWISS PRECISION MFG. CORP. 66 (E) SOUTH SECOND ST. Bayshore, NY 11706 |
| Product Code | EBL |
| CFR Regulation Number | 872.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-24 |
| Decision Date | 1990-02-14 |