The following data is part of a premarket notification filed by Ameco Medical Industries with the FDA for Amecath Cvc And Amecath Pressure Cvc Short Term Single And Multi-lumen Catherization Kits.
| Device ID | K110794 |
| 510k Number | K110794 |
| Device Name: | AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | AMECO MEDICAL INDUSTRIES 79 BROOKLINE ROAD Mason, NH 03048 |
| Contact | Ray Kelly |
| Correspondent | Ray Kelly AMECO MEDICAL INDUSTRIES 79 BROOKLINE ROAD Mason, NH 03048 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-22 |
| Decision Date | 2011-12-21 |