The following data is part of a premarket notification filed by Stortford Medical Llc with the FDA for Restep Dvy System, Model Rsp-101.
| Device ID | K090308 |
| 510k Number | K090308 |
| Device Name: | RESTEP DVY SYSTEM, MODEL RSP-101 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | STORTFORD MEDICAL LLC 295 PRINCETON HIGHTSTOWN ROAD UNIT 321 West Windsor, NJ 08550 |
| Contact | Chris Daughtery |
| Correspondent | Chris Daughtery STORTFORD MEDICAL LLC 295 PRINCETON HIGHTSTOWN ROAD UNIT 321 West Windsor, NJ 08550 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-06 |
| Decision Date | 2009-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885825020903 | K090308 | 000 |
| 30885825016839 | K090308 | 000 |
| 30885825016846 | K090308 | 000 |
| 30885825017522 | K090308 | 000 |
| 30885825017546 | K090308 | 000 |
| 30885825017577 | K090308 | 000 |
| 30885825017584 | K090308 | 000 |
| 30885825017591 | K090308 | 000 |
| 50885825018035 | K090308 | 000 |
| 30885825018055 | K090308 | 000 |
| 50885825018066 | K090308 | 000 |
| 50885825016673 | K090308 | 000 |