The following data is part of a premarket notification filed by American V. Mueller with the FDA for Quartz Retractor/probe.
Device ID | K823792 |
510k Number | K823792 |
Device Name: | QUARTZ RETRACTOR/PROBE |
Classification | Instrument, Manual, General Obstetric-gynecologic |
Applicant | AMERICAN V. MUELLER 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KOH |
CFR Regulation Number | 884.4520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-15 |
Decision Date | 1983-01-18 |