The following data is part of a premarket notification filed by Devon Medical Products (jiangsu) Ltd. with the FDA for Devon 24.
Device ID | K170814 |
510k Number | K170814 |
Device Name: | Devon 24 |
Classification | Sleeve, Limb, Compressible |
Applicant | Devon Medical Products (Jiangsu) Ltd. East Half Of 1-2f, Appt D2, 1, Qingfeng Road. Nantong, CN 226017 |
Contact | Julian Chu |
Correspondent | Julian Chu Devon Medical Products (Jiangsu) Ltd. East Half Of 1-2f, Appt D2, 1, Qingfeng Road. Nantong, CN 226017 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-17 |
Decision Date | 2017-07-11 |
Summary: | summary |