The following data is part of a premarket notification filed by Medigroup with the FDA for St-610 Needlescope Sterilization Tray.
| Device ID | K823297 |
| 510k Number | K823297 |
| Device Name: | ST-610 NEEDLESCOPE STERILIZATION TRAY |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | MEDIGROUP 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-05 |
| Decision Date | 1983-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884450260609 | K823297 | 000 |
| 00884450170144 | K823297 | 000 |