The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Guide Wire For Laporoscopic Use.
| Device ID | K926214 |
| 510k Number | K926214 |
| Device Name: | GUIDE WIRE FOR LAPOROSCOPIC USE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Sandi Hartka |
| Correspondent | Sandi Hartka TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-10 |
| Decision Date | 1993-04-29 |