The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Wallace Y-can.
| Device ID | K932947 |
| 510k Number | K932947 |
| Device Name: | WALLACE Y-CAN |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Contact | Timothy Talcott |
| Correspondent | Timothy Talcott SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-17 |
| Decision Date | 1995-09-01 |