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 |