The following data is part of a premarket notification filed by Prime Pacific Health Innovations Corporation with the FDA for Pro Fit Disposable Rectal Speculum, Models 8116 And 8117.
| Device ID | K050112 |
| 510k Number | K050112 |
| Device Name: | PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 |
| Classification | Colonic Irrigation System |
| Applicant | PRIME PACIFIC HEALTH INNOVATIONS CORPORATION 8-145 RIVERSIDE DR. North Vancouver, Bc, CA V7h 1t6 |
| Contact | Delmar Vogel |
| Correspondent | Delmar Vogel PRIME PACIFIC HEALTH INNOVATIONS CORPORATION 8-145 RIVERSIDE DR. North Vancouver, Bc, CA V7h 1t6 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-03-15 |
| Summary: | summary |