The following data is part of a premarket notification filed by Hercon Laboratories Corp. with the FDA for Hercon Antiseptic Transparent Dressing.
Device ID | K864076 |
510k Number | K864076 |
Device Name: | HERCON ANTISEPTIC TRANSPARENT DRESSING |
Classification | Tape And Bandage, Adhesive |
Applicant | HERCON LABORATORIES CORP. 200B CORPORATE COURT MIDDLESEX BUSINESS CENTER So. Plainfield, NJ 07080 |
Contact | Laura T Zeoli |
Correspondent | Laura T Zeoli HERCON LABORATORIES CORP. 200B CORPORATE COURT MIDDLESEX BUSINESS CENTER So. Plainfield, NJ 07080 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-20 |
Decision Date | 1986-12-29 |