The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for No. 86500 - Endoscopic Jet Washer.
| Device ID | K892426 |
| 510k Number | K892426 |
| Device Name: | NO. 86500 - ENDOSCOPIC JET WASHER |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Contact | Paul Bernard |
| Correspondent | Paul Bernard SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-10 |
| Decision Date | 1989-06-22 |