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 |