The following data is part of a premarket notification filed by Tz Medical Inc with the FDA for Tz Skull Pin Adult.
| Device ID | K163322 |
| 510k Number | K163322 |
| Device Name: | TZ SKULL PIN Adult |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | TZ MEDICAL INC 17750 SW UPPER BOONES FERRY RD #150 Portland, OR 97224 |
| Contact | John Lubisich |
| Correspondent | John Lubisich TZ MEDICAL INC 17750 SW UPPER BOONES FERRY RD #150 Portland, OR 97224 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-25 |
| Decision Date | 2017-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811331011357 | K163322 | 000 |