The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Fluoro Plus.
| Device ID | K861279 |
| 510k Number | K861279 |
| Device Name: | FLUORO PLUS |
| Classification | System, Image Processing, Radiological |
| Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. 306 MAIN ST. Millburn, NJ 07041 |
| Contact | Robert Follmer |
| Correspondent | Robert Follmer ADVANTAGE MEDICAL SYSTEMS, INC. 306 MAIN ST. Millburn, NJ 07041 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-07 |
| Decision Date | 1986-06-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FLUORO PLUS 73629443 1441131 Dead/Cancelled |
ADVANCED MEDICAL SYSTEMS, INC. 1986-11-10 |
![]() FLUORO PLUS 72271035 0868339 Dead/Expired |
EKCO PRODUCTS, INC. 1967-05-09 |