| Device Classification Name |
Epilator, High Frequency, Needle-Type
|
|---|
| 510(k) Number |
K941227 |
|---|
| Device Name |
SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL |
|---|
| Applicant |
| Instantron |
| 3124 Pawtucket Ave. |
|
East Providence,
RI
02915
|
|
| Applicant Contact |
STEPHEN A BONZAGNI |
| Correspondent |
| Instantron |
| 3124 Pawtucket Ave. |
|
East Providence,
RI
02915
|
|
| Correspondent Contact |
STEPHEN A BONZAGNI |
| Regulation Number | 878.5350 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/08/1994 |
|---|
| Decision Date | 08/18/1994 |
|---|
| 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
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|