The following data is part of a premarket notification filed by Renu Medical, Inc. with the FDA for Renu Medical Reporcessed Compressible Limb Sleeves.
| Device ID | K031559 |
| 510k Number | K031559 |
| Device Name: | RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES |
| Classification | Sleeve, Limb, Compressible |
| Applicant | RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett, WA 98204 |
| Contact | L. Bruce Pierson |
| Correspondent | L. Bruce Pierson RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett, WA 98204 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-19 |
| Decision Date | 2003-11-12 |
| Summary: | summary |