The following data is part of a premarket notification filed by Pro Med Instruments Gmbh with the FDA for Doro Sterile Disposable Skull Pins (stainless Steel) , Doro Sterile Disposable Skull Pins (titanium).
| Device ID | K193438 |
| 510k Number | K193438 |
| Device Name: | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | Pro Med Instruments GmbH Boetzinger Str. 38 Freiburg, DE 79111 |
| Contact | Muhammad Zubair |
| Correspondent | Muhammad Zubair Pro Med Instruments GmbH Boetzinger Str. 38 Freiburg, DE 79111 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-11 |
| Decision Date | 2020-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250435501115 | K193438 | 000 |
| 04250435501108 | K193438 | 000 |
| 04250435501092 | K193438 | 000 |
| 04250435501085 | K193438 | 000 |
| 04250435501078 | K193438 | 000 |