The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Applied Medical Laparoscopic Guidewire.
| Device ID | K971498 |
| 510k Number | K971498 |
| Device Name: | APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE |
| Classification | Stylet For Catheter, Gastro-urology |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Howard V Rowe |
| Correspondent | Howard V Rowe APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | EZB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-25 |
| Decision Date | 1997-05-05 |
| Summary: | summary |