The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Prime Zoom Stretcher.
| Device ID | K140095 |
| 510k Number | K140095 |
| Device Name: | PRIME ZOOM STRETCHER |
| Classification | Stretcher, Wheeled, Powered |
| Applicant | STRYKER CORPORATION 3800 E. CENTRE AVE Portage, MI 49002 |
| Contact | Matthew W Jordan |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | INK |
| CFR Regulation Number | 890.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-01-14 |
| Decision Date | 2014-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327278323 | K140095 | 000 |
| 07613327278316 | K140095 | 000 |
| 07613327278293 | K140095 | 000 |
| 07613327278286 | K140095 | 000 |