The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Wire Guided Oval Dilators.
| Device ID | K930465 |
| 510k Number | K930465 |
| Device Name: | WIRE GUIDED OVAL DILATORS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SURGICAL TECHNOLOGIES, INC. 4715 N.W. 157TH ST., SUITE 212 Miami Lakes, FL 33014 |
| Contact | Laszlo Fazekas |
| Correspondent | Laszlo Fazekas SURGICAL TECHNOLOGIES, INC. 4715 N.W. 157TH ST., SUITE 212 Miami Lakes, FL 33014 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-28 |
| Decision Date | 1993-05-21 |