The following data is part of a premarket notification filed by Ossaware Biotech Co., Ltd. with the FDA for Flap Fixator, Burr Hole Cover.
| Device ID | K192310 |
| 510k Number | K192310 |
| Device Name: | Flap Fixator, Burr Hole Cover |
| Classification | Cover, Burr Hole |
| Applicant | Ossaware Biotech Co., Ltd. No. 51, Xinggong Rd. Shenkang Hsiang, TW 50971 |
| Contact | Meng Feng Huang |
| Correspondent | Meng Feng Huang Ossaware Biotech Co., Ltd. No. 51, Xinggong Rd. Shenkang Hsiang, TW 50971 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-26 |
| Decision Date | 2020-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04717002404335 | K192310 | 000 |
| 14717002404325 | K192310 | 000 |
| 14717002404172 | K192310 | 000 |
| 14717002404165 | K192310 | 000 |