The following data is part of a premarket notification filed by Relievant Medsystems with the FDA for Relievant Medsystems Rf Generator.
Device ID | K171143 |
510k Number | K171143 |
Device Name: | Relievant Medsystems RF Generator |
Classification | Generator, Lesion, Radiofrequency |
Applicant | Relievant Medsystems 2688 Middlefield Road, Suite A Redwood City, CA 94063 |
Contact | Alex Dinello |
Correspondent | Laurie Hook Relievant Medsystems 2688 Middlefield Road, Suite A Redwood City, CA 94063 |
Product Code | GXD |
CFR Regulation Number | 882.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-18 |
Decision Date | 2017-08-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00852454006066 | K171143 | 000 |