The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Torpicalgin.
| Device ID | K043131 |
| 510k Number | K043131 |
| Device Name: | TORPICALGIN |
| Classification | Material, Impression |
| Applicant | ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Contact | Gerald W Shipps |
| Correspondent | Gerald W Shipps ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-12 |
| Decision Date | 2004-12-15 |