The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Sharpoint Lukens Bone Wax.
| Device ID | K050292 |
| 510k Number | K050292 |
| Device Name: | SHARPOINT LUKENS BONE WAX |
| Classification | Wax, Bone |
| Applicant | SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Contact | Elizabeth Lazaro |
| Correspondent | Elizabeth Lazaro SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Product Code | MTJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-07 |
| Decision Date | 2005-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782008268 | K050292 | 000 |
| 10848782005625 | K050292 | 000 |
| 34026704635659 | K050292 | 000 |