The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Precision Hd Camera System.
| Device ID | K142603 |
| 510k Number | K142603 |
| Device Name: | Stryker Precision HD Camera System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 |
| Contact | Angela Wong |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-09-15 |
| Decision Date | 2014-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327145687 | K142603 | 000 |
| 07613327063318 | K142603 | 000 |
| 07613327063325 | K142603 | 000 |
| 07613327063332 | K142603 | 000 |
| 07613327063349 | K142603 | 000 |
| 07613327063356 | K142603 | 000 |
| 07613327063363 | K142603 | 000 |
| 07613327063370 | K142603 | 000 |
| 07613327137354 | K142603 | 000 |
| 07613327137361 | K142603 | 000 |
| 07613327137378 | K142603 | 000 |
| 07613327144833 | K142603 | 000 |
| 07613327054682 | K142603 | 000 |