The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Tendon Harvester.
| Device ID | K880414 |
| 510k Number | K880414 |
| Device Name: | TENDON HARVESTER |
| Classification | Arthroscope |
| Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Contact | Martha C Miller |
| Correspondent | Martha C Miller 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 | 1988-02-01 |
| Decision Date | 1988-03-25 |