The following data is part of a premarket notification filed by Caremed Supply, Inc. with the FDA for Vesoflow Plus Dvt Compression Device.
Device ID | K141064 |
510k Number | K141064 |
Device Name: | VESOFLOW PLUS DVT COMPRESSION DEVICE |
Classification | Sleeve, Limb, Compressible |
Applicant | CAREMED SUPPLY, INC. NO.45, MINSHENG RD. DANSHUI TOWN New Taipei City, TW 251 |
Contact | Michael Lee |
Correspondent | Michael Lee CAREMED SUPPLY, INC. NO.45, MINSHENG RD. DANSHUI TOWN New Taipei City, TW 251 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-24 |
Decision Date | 2014-12-04 |
Summary: | summary |