Pre-market Notification Details
Device ID | K832299 |
510k Number | K832299 |
Device Name: | VISI-FLOW IRRIGATOR |
Classification | Irrigator, Ostomy |
Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EXD |
CFR Regulation Number | 876.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-13 |
Decision Date | 1983-08-26 |
NIH GUDID Devices
Device Identifier | submissionNumber | Supplement |
00768455104253 |
K832299 |
000 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.