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 | K052740 |
510k Number | K052740 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-30 |
Decision Date | 2005-10-17 |
Summary: | summary |