The following data is part of a premarket notification filed by Orthoconcept, Inc. with the FDA for Arthro-fms-3/irrigation Sets (various).
| Device ID | K905785 |
| 510k Number | K905785 |
| Device Name: | ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS) |
| Classification | Arthroscope |
| Applicant | ORTHOCONCEPT, INC. 8 COLD BRANCH CT Columbia, SC 29223 |
| Contact | Jack Defranco |
| Correspondent | Jack Defranco ORTHOCONCEPT, INC. 8 COLD BRANCH CT Columbia, SC 29223 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-19 |
| Decision Date | 1991-03-26 |