The following data is part of a premarket notification filed by Conmed Integrated Systems (cmis) with the FDA for Nurse's Assistant 1.7 O.r. Control System.
| Device ID | K050829 |
| 510k Number | K050829 |
| Device Name: | NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CONMED INTEGRATED SYSTEMS (CMIS) 1815 NW 169TH PLACE SUITE 4020 Beaverton, OR 97006 |
| Contact | C. Jeff Lipps |
| Correspondent | C. Jeff Lipps CONMED INTEGRATED SYSTEMS (CMIS) 1815 NW 169TH PLACE SUITE 4020 Beaverton, OR 97006 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-01 |
| Decision Date | 2005-05-06 |
| Summary: | summary |