The following data is part of a premarket notification filed by I.b. Bloxom C/o Hogan & Hartson with the FDA for Bloxom Irrigator.
| Device ID | K871791 |
| 510k Number | K871791 |
| Device Name: | BLOXOM IRRIGATOR |
| Classification | Irrigator, Ostomy |
| Applicant | I.B. BLOXOM C/O HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan I.B. BLOXOM C/O HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | EXD |
| CFR Regulation Number | 876.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-07 |
| Decision Date | 1987-05-20 |