The following data is part of a premarket notification filed by Lpg One, Inc with the FDA for Cellu M6 Keymodule I.
Device ID | K053225 |
510k Number | K053225 |
Device Name: | CELLU M6 KEYMODULE I |
Classification | Massager, Therapeutic, Electric |
Applicant | LPG ONE, INC 845 ARONSON LAKE COURT Roswell, GA 30075 |
Contact | Jay Mansour |
Correspondent | Jay Mansour LPG ONE, INC 845 ARONSON LAKE COURT Roswell, GA 30075 |
Product Code | ISA |
CFR Regulation Number | 890.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-11-17 |
Decision Date | 2006-11-06 |
Summary: | summary |