The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Plat. Class 3 French Ureteroscopic Flat Wire Stone, Torque Helical Stone Baskets/grasping Forceps.
| Device ID | K961248 |
| 510k Number | K961248 |
| Device Name: | BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Donna J Wilson |
| Correspondent | Donna J Wilson C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-01 |
| Decision Date | 1996-05-28 |
| Summary: | summary |