The following data is part of a premarket notification filed by Oldelft Corp. Of America with the FDA for Papillion Proctoscope.
| Device ID | K914784 |
| 510k Number | K914784 |
| Device Name: | PAPILLION PROCTOSCOPE |
| Classification | Device, Beam Limiting, X-ray, Therapeutic |
| Applicant | OLDELFT CORP. OF AMERICA 2735 DORR AVE. Fairfax, VA 22031 |
| Contact | Charles Pattie |
| Correspondent | Charles Pattie OLDELFT CORP. OF AMERICA 2735 DORR AVE. Fairfax, VA 22031 |
| Product Code | KQA |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-23 |
| Decision Date | 1992-06-05 |