The following data is part of a premarket notification filed by Scientific Device Manufacturer Llc. with the FDA for Percuglide.
| Device ID | K960917 |
| 510k Number | K960917 |
| Device Name: | PERCUGLIDE |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael, CA 94901 |
| Contact | Richard C Ball |
| Correspondent | Richard C Ball SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael, CA 94901 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-06 |
| Decision Date | 1996-07-02 |
| Summary: | summary |