The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Brainlab Headpins.
| Device ID | K954789 |
| 510k Number | K954789 |
| Device Name: | BRAINLAB HEADPINS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | BRAINLAB, AG 600 GLEN COURT Moorestown, NJ 08057 |
| Contact | Stefan Lip[pstreu |
| Correspondent | Stefan Lip[pstreu BRAINLAB, AG 600 GLEN COURT Moorestown, NJ 08057 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-18 |
| Decision Date | 1996-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481004033 | K954789 | 000 |
| 04056481003937 | K954789 | 000 |
| 04056481003944 | K954789 | 000 |
| 04056481003951 | K954789 | 000 |
| 04056481003968 | K954789 | 000 |
| 04056481003975 | K954789 | 000 |
| 04056481003982 | K954789 | 000 |
| 04056481003999 | K954789 | 000 |
| 04056481004002 | K954789 | 000 |
| 04056481004019 | K954789 | 000 |
| 04056481004026 | K954789 | 000 |
| 04056481003920 | K954789 | 000 |