The following data is part of a premarket notification filed by Caremed Supply, Inc. with the FDA for Vesoflow.
Device ID | K110977 |
510k Number | K110977 |
Device Name: | VESOFLOW |
Classification | Sleeve, Limb, Compressible |
Applicant | CAREMED SUPPLY, INC. 5905 FAWN LANE Cleveland, OH 44141 |
Contact | Edward A Kroll |
Correspondent | Edward A Kroll CAREMED SUPPLY, INC. 5905 FAWN LANE Cleveland, OH 44141 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-07 |
Decision Date | 2011-08-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884389683729 | K110977 | 000 |
10884389684573 | K110977 | 000 |
10889942472819 | K110977 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VESOFLOW 85238925 4208554 Live/Registered |
CAREMED SUPPLY INC. 2011-02-10 |