The following data is part of a premarket notification filed by Smith & Nephew Medical Limited with the FDA for Renasys Y-connector; Renasys Touch.
Device ID | K181204 |
510k Number | K181204 |
Device Name: | RENASYS Y-Connector; RENASYS TOUCH |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | Smith & Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
Contact | Sam Greenhalgh |
Correspondent | Sam Greenhalgh Smith & Nephew Medical Limited 101 Hessle Road Hull, GB Hu3 2bn |
Product Code | OMP |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-07 |
Decision Date | 2019-01-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05000223493592 | K181204 | 000 |
05000223496296 | K181204 | 000 |
05000223494476 | K181204 | 000 |