The following data is part of a premarket notification filed by Acme United Corp. with the FDA for One Time Hyperal & Catheter Dressing Change Trays.
| Device ID | K861015 |
| 510k Number | K861015 |
| Device Name: | ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | ACME UNITED CORP. 425 POST RD. Fairfield, CT 06430 |
| Contact | Susan L Carey |
| Correspondent | Susan L Carey ACME UNITED CORP. 425 POST RD. Fairfield, CT 06430 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-04-22 |