The following data is part of a premarket notification filed by Hk Surgical with the FDA for Subqkath Catheter And Needle Set.
| Device ID | K193664 |
| 510k Number | K193664 |
| Device Name: | SubQKath Catheter And Needle Set |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | HK Surgical 1271 Puerto Del Sol San Clemente, CA 92673 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik HK Surgical 1271 Puerto Del Sol San Clemente, CA 92673 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-31 |
| Decision Date | 2020-09-09 |