The following data is part of a premarket notification filed by Vevazz, Llc with the FDA for Vevazz Led Heat Lamp.
Device ID | K162763 |
510k Number | K162763 |
Device Name: | Vevazz LED Heat Lamp |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | Vevazz, LLC 30520 Rancho California Rd, Suite 107-46 Temecula, CA 92591 |
Contact | Jamie Fettig |
Correspondent | Jamie Fettig Vevazz, LLC 30520 Rancho California Rd, Suite 107-46 Temecula, CA 92591 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-09-30 |
Decision Date | 2017-01-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B552VEVAZZLCD0 | K162763 | 000 |