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 |