The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Ultra Iii.
Device ID | K921952 |
510k Number | K921952 |
Device Name: | ULTRA III |
Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
Applicant | EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
Contact | John Mumford |
Correspondent | John Mumford EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
Product Code | IMG |
CFR Regulation Number | 890.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-27 |
Decision Date | 1993-03-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ULTRA III 76305515 2671489 Dead/Cancelled |
PLASTIC SPECIALTIES MANUFACTURING, INC. 2001-08-28 |
ULTRA III 76305514 2615027 Dead/Cancelled |
C&A PRO, LLC 2001-08-28 |