| Device Classification Name |
Dressing, Wound, Drug
|
| 510(k) Number |
K871255 |
| Device Name |
MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING |
| Applicant |
| Hercon Laboratories Corp. |
| 200b Corporate Ct. |
| Middlesex Business Center |
|
So. Plainfield,
NJ
07080
|
|
| Applicant Contact |
JANINE LAURENCOT |
| Correspondent |
| Hercon Laboratories Corp. |
| 200b Corporate Ct. |
| Middlesex Business Center |
|
So. Plainfield,
NJ
07080
|
|
| Correspondent Contact |
JANINE LAURENCOT |
| Classification Product Code |
|
| Date Received | 03/31/1987 |
| Decision Date | 05/29/1987 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|