The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Vision Elect Whdtv (stryker Ve Whdtv).
| Device ID | K081995 |
| 510k Number | K081995 |
| Device Name: | STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Monica Barrett |
| Correspondent | Monica Barrett Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-14 |
| Decision Date | 2008-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327056075 | K081995 | 000 |
| 07613327056068 | K081995 | 000 |
| 07613327056051 | K081995 | 000 |
| 07613327056044 | K081995 | 000 |
| 07613327056037 | K081995 | 000 |