Submission Details
| 510(k) Number | K871791 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 07, 1987 |
| Decision Date | May 20, 1987 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
BLOXOM IRRIGATOR
May 1987
Decision
13d
Days
Class 2
Risk
About This 510(k) Submission
K871791 is an FDA 510(k) clearance for the BLOXOM IRRIGATOR, a Irrigator, Ostomy (Class II — Special Controls, product code EXD), submitted by I.B. Bloxom C/O Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on May 20, 1987, 13 days after receiving the submission on May 7, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5895.
Device Classification
| Product Code | EXD — Irrigator, Ostomy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5895 |
Manufacturer
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