The following data is part of a premarket notification filed by Universal Fiberoptic Repair, Inc. with the FDA for Ufr Fiberoptic Cable.
| Device ID | K972225 |
| 510k Number | K972225 |
| Device Name: | UFR FIBEROPTIC CABLE |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | UNIVERSAL FIBEROPTIC REPAIR, INC. 9 WRIGHTS CROSSING Pomfret Center, CT 06259 |
| Contact | Derek N May |
| Correspondent | Derek N May UNIVERSAL FIBEROPTIC REPAIR, INC. 9 WRIGHTS CROSSING Pomfret Center, CT 06259 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-13 |
| Decision Date | 1998-03-18 |