The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Constavac.
| Device ID | K823284 |
| 510k Number | K823284 |
| Device Name: | STRYKER CONSTAVAC |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | STRYKER CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-04 |
| Decision Date | 1983-01-14 |