The following data is part of a premarket notification filed by Mobit, Inc. with the FDA for Tweezer-type Epilator.
Device ID | K973340 |
510k Number | K973340 |
Device Name: | TWEEZER-TYPE EPILATOR |
Classification | Epilator, High Frequency, Tweezer-type |
Applicant | MOBIT, INC. 420 LEXINGTON AVE. New York, NY 10170 |
Contact | James R Marshall |
Correspondent | James R Marshall MOBIT, INC. 420 LEXINGTON AVE. New York, NY 10170 |
Product Code | KCX |
CFR Regulation Number | 878.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-05 |
Decision Date | 1997-12-03 |