The following data is part of a premarket notification filed by Hercon Laboratories Corp. with the FDA for Hercon Anti. Trans. Dressing As A Wound Dressing.
Device ID | K870743 |
510k Number | K870743 |
Device Name: | HERCON ANTI. TRANS. DRESSING AS A WOUND 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 | 1987-02-10 |
Decision Date | 1987-04-06 |