The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Propper Sigmoidoscope Suction Instrument.
| Device ID | K810506 |
| 510k Number | K810506 |
| Device Name: | PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | PROPPER MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-24 |
| Decision Date | 1981-04-07 |