The following data is part of a premarket notification filed by Wong Way Corporation with the FDA for Wwmed, Model 401.
Device ID | K051961 |
510k Number | K051961 |
Device Name: | WWMED, MODEL 401 |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | WONG WAY CORPORATION 1151 HOPE STREET Stamford, CT 06907 |
Contact | Richard Keen |
Correspondent | Richard Keen WONG WAY CORPORATION 1151 HOPE STREET Stamford, CT 06907 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-19 |
Decision Date | 2006-02-10 |
Summary: | summary |