The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Suction Regulator.
| Device ID | K963648 |
| 510k Number | K963648 |
| Device Name: | STRYKER SUCTION REGULATOR |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Anthony Lee |
| Correspondent | Anthony Lee Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-12 |
| Decision Date | 1996-11-26 |
| Summary: | summary |