The following data is part of a premarket notification filed by Safte S.p.a. with the FDA for Safte Orione Hernia Belt Items No. 316, 515, 536.
| Device ID | K901922 |
| 510k Number | K901922 |
| Device Name: | SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 |
| Classification | Support, Hernia |
| Applicant | SAFTE S.P.A. VIA TRECATE, 9/A 10141 TORINO Italia, IT |
| Contact | Zanella |
| Correspondent | Zanella SAFTE S.P.A. VIA TRECATE, 9/A 10141 TORINO Italia, IT |
| Product Code | EXN |
| CFR Regulation Number | 876.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-30 |
| Decision Date | 1990-10-26 |