The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for Sterile Water Solution Catalog # 10000.
| Device ID | K904216 |
| 510k Number | K904216 |
| Device Name: | STERILE WATER SOLUTION CATALOG # 10000 |
| Classification | Catheter And Tip, Suction |
| Applicant | SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Contact | Maureen G Mccabe |
| Correspondent | Maureen G Mccabe SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-12 |
| Decision Date | 1990-11-16 |