The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Incl Endoscope.
| Device ID | K955471 |
| 510k Number | K955471 |
| Device Name: | INCL ENDOSCOPE |
| Classification | Arthroscope |
| Applicant | SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Threharne |
| Correspondent | Richard W Threharne SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-10 |
| Decision Date | 1995-12-18 |