The following data is part of a premarket notification filed by Universal H.r. System, Inc. with the FDA for Epi 2.
Device ID | K935706 |
510k Number | K935706 |
Device Name: | EPI 2 |
Classification | Epilator, High Frequency, Tweezer-type |
Applicant | UNIVERSAL H.R. SYSTEM, INC. 4601 W. KENNEDY BLVD., SUITE 107 Tampa, FL 33609 |
Contact | William H Simpson |
Correspondent | William H Simpson UNIVERSAL H.R. SYSTEM, INC. 4601 W. KENNEDY BLVD., SUITE 107 Tampa, FL 33609 |
Product Code | KCX |
CFR Regulation Number | 878.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-30 |
Decision Date | 1997-02-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EPI 2 75474217 not registered Dead/Abandoned |
Universal Hair Removal System, Inc. 1998-04-24 |