The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Ulrich Transfer Set.
| Device ID | K161723 |
| 510k Number | K161723 |
| Device Name: | Ulrich Transfer Set |
| Classification | Iodinated Contrast Media Transfer Tubing Set |
| Applicant | ulrich GmbH & Co. KG Buchbrunnenweg 12 Ulm, DE 89081 |
| Contact | Sven Erdmann |
| Correspondent | Rita King MethodSense, Inc. PO Box 110352 Durham, NC 27709 |
| Product Code | PQH |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-06-22 |
| Decision Date | 2016-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04052536184088 | K161723 | 000 |