Device Classification Name |
Transducer, Ultrasonic, Diagnostic
|
510(k) Number |
K961757 |
Device Name |
ECOGEL 100 ULTRASOUND GEL |
Applicant |
ECO-MED PHARMACEUTICALS, INC. |
6155 TOMKEN ROAD |
UNIT 13 |
MISSISSAUGA, ONTARIO,
CA
L4W 1H3
|
|
Applicant Contact |
PAUL L HOOEY |
Correspondent |
ECO-MED PHARMACEUTICALS, INC. |
6155 TOMKEN ROAD |
UNIT 13 |
MISSISSAUGA, ONTARIO,
CA
L4W 1H3
|
|
Correspondent Contact |
PAUL L HOOEY |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 05/06/1996 |
Decision Date | 07/25/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|