The following data is part of a premarket notification filed by Thermotek, Inc. with the FDA for Vascucomp.
Device ID | K103247 |
510k Number | K103247 |
Device Name: | VASCUCOMP |
Classification | Sleeve, Limb, Compressible |
Applicant | THERMOTEK, INC. 1200 LAKESIDE PARKWAY #200 Flower Mound, TX 75028 |
Contact | Niran Balachandran |
Correspondent | William J Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-11-03 |
Decision Date | 2010-12-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816305023374 | K103247 | 000 |
00816305020977 | K103247 | 000 |
00816305020984 | K103247 | 000 |
00816305020991 | K103247 | 000 |
00816305021004 | K103247 | 000 |
00816305021011 | K103247 | 000 |
00816305021028 | K103247 | 000 |
00816305021035 | K103247 | 000 |
00816305021042 | K103247 | 000 |
00816305021059 | K103247 | 000 |
00816305021066 | K103247 | 000 |
00816305021073 | K103247 | 000 |
00816305021080 | K103247 | 000 |
00816305020960 | K103247 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VASCUCOMP 85159094 4082160 Live/Registered |
ThermoTek, Inc. 2010-10-22 |