The following data is part of a premarket notification filed by American Medical Manufacturing, Inc./ Advanced Med with the FDA for Medmate Transfer Adapter Am5500 & Am5500-ns.
| Device ID | K130097 |
| 510k Number | K130097 |
| Device Name: | MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | AMERICAN MEDICAL MANUFACTURING, INC./ ADVANCED MED 8741 Shirley Ave Northridge, CA 91324 |
| Contact | Mike Hoftman |
| Correspondent | Mike Hoftman AMERICAN MEDICAL MANUFACTURING, INC./ ADVANCED MED 8741 Shirley Ave Northridge, CA 91324 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-15 |
| Decision Date | 2014-07-22 |
| Summary: | summary |