The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover.
| Device ID | K152342 |
| 510k Number | K152342 |
| Device Name: | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover |
| Classification | Cover, Burr Hole |
| Applicant | ST. JUDE MEDICAL 6901 PRESTON ROAD Plano, TX 75024 |
| Contact | Parita Mehta |
| Correspondent | Manasi Khare ST. JUDE MEDICAL 15900 Valley View Court Sylmar, CA 91342 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-19 |
| Decision Date | 2016-06-09 |
| Summary: | summary |