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 |