The following data is part of a premarket notification filed by Orthoconcept, Inc. with the FDA for Orthoconcept Arthroscopic Pump.
| Device ID | K910164 |
| 510k Number | K910164 |
| Device Name: | ORTHOCONCEPT ARTHROSCOPIC PUMP |
| Classification | Arthroscope |
| Applicant | ORTHOCONCEPT, INC. 605 EAST 63RD. ST. SUITE 7A New York City, NY 10021 |
| Contact | Jack Defranco |
| Correspondent | Jack Defranco ORTHOCONCEPT, INC. 605 EAST 63RD. ST. SUITE 7A New York City, NY 10021 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-15 |
| Decision Date | 1991-03-27 |