The following data is part of a premarket notification filed by Altomec Endoscopy Inc with the FDA for Altomec Arthroscope.
| Device ID | K112548 |
| 510k Number | K112548 |
| Device Name: | ALTOMEC ARTHROSCOPE |
| Classification | Arthroscope |
| Applicant | ALTOMEC ENDOSCOPY INC 7305 HANCOCK VILLAGE DR. SUITE 109 Chesterfield, VA 23832 |
| Contact | Darren Reeves |
| Correspondent | Darren Reeves ALTOMEC ENDOSCOPY INC 7305 HANCOCK VILLAGE DR. SUITE 109 Chesterfield, VA 23832 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-01 |
| Decision Date | 2012-08-15 |
| Summary: | summary |