The following data is part of a premarket notification filed by Medical Resources, Ltd. with the FDA for Phyne-vu.
| Device ID | K885096 |
| 510k Number | K885096 |
| Device Name: | PHYNE-VU |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDICAL RESOURCES, LTD. 520 WEST BRANNEN RD. Lakeland, FL 33813 |
| Contact | Richard H Ghenn |
| Correspondent | Richard H Ghenn MEDICAL RESOURCES, LTD. 520 WEST BRANNEN RD. Lakeland, FL 33813 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-09 |
| Decision Date | 1989-07-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PHYNE-VU 73754533 1540060 Dead/Cancelled |
MEDICAL RESOURCES INTERNATIONAL, INC. 1988-09-28 |