The following data is part of a premarket notification filed by Stradis Healthcare with the FDA for Unger Quad Injector.
| Device ID | K161483 |
| 510k Number | K161483 |
| Device Name: | Unger Quad Injector |
| Classification | Expander, Skin, Inflatable |
| Applicant | STRADIS HEALTHCARE 805 MARATHON PKWY SUITE 100 Lawrenceville, GA 30046 |
| Contact | Joseph Trznadel |
| Correspondent | H. Carl Jenkins Wood Burditt Group 10 E. Scranton Ave., Ste. 201 Lake Bluff, IL 60044 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-31 |
| Decision Date | 2016-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888628043619 | K161483 | 000 |
| 10888628043602 | K161483 | 000 |