The following data is part of a premarket notification filed by Hercon Laboratories Corp. with the FDA for Modified Hercon Antiseptic Transparent Dressing.
| Device ID | K871255 |
| 510k Number | K871255 |
| Device Name: | MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | HERCON LABORATORIES CORP. 200B CORPORATE COURT MIDDLESEX BUSINESS CENTER So. Plainfield, NJ 07080 |
| Contact | Janine Laurencot |
| Correspondent | Janine Laurencot HERCON LABORATORIES CORP. 200B CORPORATE COURT MIDDLESEX BUSINESS CENTER So. Plainfield, NJ 07080 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-31 |
| Decision Date | 1987-05-29 |