The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Look Collagen Spacers, Model 1514b.
| Device ID | K001765 |
| 510k Number | K001765 |
| Device Name: | LOOK COLLAGEN SPACERS, MODEL 1514B |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Contact | Linda F Texter |
| Correspondent | Linda F Texter SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-12 |
| Decision Date | 2000-09-07 |