The following data is part of a premarket notification filed by Stryker Medical with the FDA for Power-load Cot Fastener System.
| Device ID | K113598 |
| 510k Number | K113598 |
| Device Name: | POWER-LOAD COT FASTENER SYSTEM |
| Classification | Stretcher, Wheeled |
| Applicant | STRYKER MEDICAL 3800 E. CENTRE AVE. Portage, MI 49002 |
| Contact | Renata Sila |
| Correspondent | Bhavesh V Sheth INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FPO |
| CFR Regulation Number | 880.6910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-12-05 |
| Decision Date | 2011-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327394740 | K113598 | 000 |
| 07613327261523 | K113598 | 000 |
| 07613327504453 | K113598 | 000 |