Device Classification Name |
Light Source, Fiberoptic, Routine
|
510(k) Number |
K942155 |
Device Name |
HMT ENDOSCREEN, MODEL ESC 501 |
Applicant |
SERVICETRENDS, INC. |
2130 BARRETT PARK DRIVE N.E. |
SUITE 103 |
KENNESAW,
GA
30144
|
|
Applicant Contact |
JOHN WARLICK |
Correspondent |
SERVICETRENDS, INC. |
2130 BARRETT PARK DRIVE N.E. |
SUITE 103 |
KENNESAW,
GA
30144
|
|
Correspondent Contact |
JOHN WARLICK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/03/1994 |
Decision Date | 07/01/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|