The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Model Ar-6300 Infusion Pump.
| Device ID | K915721 |
| 510k Number | K915721 |
| Device Name: | MODEL AR-6300 INFUSION PUMP |
| Classification | Arthroscope |
| Applicant | ARTHREX, INC. 1963 ROCK ST. SUITE17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose ARTHREX, INC. 1963 ROCK ST. SUITE17 Mountain View, CA 94043 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-20 |
| Decision Date | 1992-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888867039336 | K915721 | 000 |