The following data is part of a premarket notification filed by Sterile Design, Inc. with the FDA for Graduated Guide Wire Bowl 8.
| Device ID | K834237 |
| 510k Number | K834237 |
| Device Name: | GRADUATED GUIDE WIRE BOWL 8 |
| Classification | Wire, Guide, Catheter |
| Applicant | STERILE DESIGN, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-06 |
| Decision Date | 1984-02-04 |