The following data is part of a premarket notification filed by Compactcath, Inc. with the FDA for Compactcath Lubricated Intermittent Urinarycatheter And Onecath Intermittent Urinary Catheter.
| Device ID | K180738 |
| 510k Number | K180738 |
| Device Name: | COMPACTCATH Lubricated Intermittent UrinaryCatheter And OneCath Intermittent Urinary Catheter |
| Classification | Catheter, Straight |
| Applicant | Compactcath, Inc. 887 Federation Way Palo Alto, CA 94303 |
| Contact | Naama S. Breckler |
| Correspondent | Tehyen Chu ATOM Health Corporation 12F., No.122 Songjiang Rd. Taipei City, TW 104 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-22 |
| Decision Date | 2018-06-14 |
| Summary: | summary |