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 |
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