The following data is part of a premarket notification filed by United Fortune International, Inc. with the FDA for Endoscopic Reposable Tip Surgical Instruments.
| Device ID | K944954 |
| 510k Number | K944954 |
| Device Name: | ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNITED FORTUNE INTERNATIONAL, INC. 3960 E. MIRALOMA AVE. Anaheim, CA 92806 |
| Contact | Karin Dolan |
| Correspondent | Karin Dolan UNITED FORTUNE INTERNATIONAL, INC. 3960 E. MIRALOMA AVE. Anaheim, CA 92806 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-07 |
| Decision Date | 1994-11-08 |