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 |