Device Classification Name |
Epilator, High Frequency, Needle-Type
|
510(k) Number |
K943399 |
Device Name |
THE SS-99 |
Applicant |
INSTANTRON |
3124 PAWTUCKET AVE. |
EAST PROVIDENCE,
RI
02915 -5195
|
|
Applicant Contact |
STEPHEN A BONZAGNI |
Correspondent |
INSTANTRON |
3124 PAWTUCKET AVE. |
EAST PROVIDENCE,
RI
02915 -5195
|
|
Correspondent Contact |
STEPHEN A BONZAGNI |
Regulation Number | 878.5350
|
Classification Product Code |
|
Date Received | 07/14/1994 |
Decision Date | 09/16/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|