The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Q-5000.
| Device ID | K961971 |
| 510k Number | K961971 |
| Device Name: | Q-5000 |
| Classification | Light, Surgical, Floor Standing |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Bader-e Bellahsene, Ph.d. |
| Correspondent | Bader-e Bellahsene, Ph.d. Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | FSS |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-20 |
| Decision Date | 1996-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327051360 | K961971 | 000 |