The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Inclusice Ii(tm) Endoscope.
| Device ID | K946087 |
| 510k Number | K946087 |
| Device Name: | INCLUSICE II(TM) ENDOSCOPE |
| Classification | Arthroscope |
| Applicant | SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-13 |
| Decision Date | 1995-11-21 |