The following data is part of a premarket notification filed by Instantron with the FDA for The Ss-99.
Device ID | K943399 |
510k Number | K943399 |
Device Name: | THE SS-99 |
Classification | Epilator, High Frequency, Needle-type |
Applicant | INSTANTRON 3124 PAWTUCKET AVE. East Providence, RI 02915 -5195 |
Contact | Stephen A Bonzagni |
Correspondent | Stephen A Bonzagni INSTANTRON 3124 PAWTUCKET AVE. East Providence, RI 02915 -5195 |
Product Code | KCW |
CFR Regulation Number | 878.5350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-14 |
Decision Date | 1994-09-16 |