The following data is part of a premarket notification filed by Northgate Technologies Inc. with the FDA for Autolith Touch; Uro Touch.
| Device ID | K130368 |
| 510k Number | K130368 |
| Device Name: | AUTOLITH TOUCH; URO TOUCH |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | NORTHGATE TECHNOLOGIES INC. 1591 SCOTTSDALE COURT Elgin, IL 60123 |
| Contact | Casey Kurek |
| Correspondent | Casey Kurek NORTHGATE TECHNOLOGIES INC. 1591 SCOTTSDALE COURT Elgin, IL 60123 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-14 |
| Decision Date | 2013-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817183020561 | K130368 | 000 |
| 00817183020028 | K130368 | 000 |
| 00817183020059 | K130368 | 000 |
| 00817183020066 | K130368 | 000 |
| 00817183020073 | K130368 | 000 |
| 00817183020080 | K130368 | 000 |
| 00817183020103 | K130368 | 000 |
| 00817183020110 | K130368 | 000 |
| 00817183020448 | K130368 | 000 |
| 00817183020455 | K130368 | 000 |
| 00817183020462 | K130368 | 000 |
| 00817183020479 | K130368 | 000 |
| 00817183020493 | K130368 | 000 |
| 00817183020523 | K130368 | 000 |
| 00817183020530 | K130368 | 000 |
| 00817183020547 | K130368 | 000 |
| 00817183020554 | K130368 | 000 |
| 00817183020004 | K130368 | 000 |