The following data is part of a premarket notification filed by Full Power Aed with the FDA for Rapid Hair Removal Pads.
Device ID | K150349 |
510k Number | K150349 |
Device Name: | Rapid Hair Removal Pads |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
Applicant | FULL POWER AED 707 East Hudson Ave Durham, NC 27704 |
Contact | Jahn Power |
Correspondent | Jahn Power FULL POWER AED 707 East Hudson Ave Durham, NC 27704 |
Product Code | LDD |
CFR Regulation Number | 870.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-11 |
Decision Date | 2015-07-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00867855000308 | K150349 | 000 |