The following data is part of a premarket notification filed by Acme United Corp. with the FDA for Acu-derm Transparent Iv Dressing.
| Device ID | K842064 |
| 510k Number | K842064 |
| Device Name: | ACU-DERM TRANSPARENT IV DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | ACME UNITED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-21 |
| Decision Date | 1984-08-15 |