The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Arthroscopy Fluid Mgmt. System.
Device ID | K832315 |
510k Number | K832315 |
Device Name: | ARTHROSCOPY FLUID MGMT. SYSTEM |
Classification | Arthroscope |
Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-14 |
Decision Date | 1983-10-04 |