The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Arthroscopic Portal Rod.
| Device ID | K873030 |
| 510k Number | K873030 |
| Device Name: | CONCEPT ARTHROSCOPIC PORTAL ROD |
| Classification | Arthroscope |
| Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Contact | Lori Colvin |
| Correspondent | Lori Colvin 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 | 1987-08-04 |
| Decision Date | 1987-09-16 |