The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Suction Reservoir - Model Number: 910-500.
| Device ID | K963839 |
| 510k Number | K963839 |
| Device Name: | CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Stephen M Enos |
| Correspondent | Stephen M Enos CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-24 |
| Decision Date | 1996-12-12 |
| Summary: | summary |