The following data is part of a premarket notification filed by Scholly Fiberoptic Gmbh with the FDA for Schoelly Arthroscope.
| Device ID | K133682 |
| 510k Number | K133682 |
| Device Name: | SCHOELLY ARTHROSCOPE |
| Classification | Arthroscope |
| Applicant | SCHOLLY FIBEROPTIC GMBH 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineau, Rac |
| Correspondent | Pamela Papineau, Rac SCHOLLY FIBEROPTIC GMBH 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-02 |
| Decision Date | 2014-06-02 |