The following data is part of a premarket notification filed by Medigroup with the FDA for Medigroup 2.2mm Needlescope Cannula&.
Device ID | K823295 |
510k Number | K823295 |
Device Name: | MEDIGROUP 2.2MM NEEDLESCOPE CANNULA& |
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 |
---|---|---|
00884450248119 | K823295 | 000 |
00884450170120 | K823295 | 000 |