The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Intravision Arthroscope System.
| Device ID | K863396 |
| 510k Number | K863396 |
| Device Name: | CONCEPT INTRAVISION ARTHROSCOPE SYSTEM |
| Classification | Arthroscope |
| Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Contact | Penny Rasmussen |
| Correspondent | Penny Rasmussen CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-03 |
| Decision Date | 1986-09-12 |