Device Classification Name |
light source, endoscope, xenon arc
|
510(k) Number |
K980281 |
Device Name |
WELCH ALLYN XENON 300 LIGHT SOURCE |
Applicant |
WELCH ALLYN, INC. |
4619 JORDAN RD. |
SKANEATELES FALLS,
NY
13153 -0187
|
|
Applicant Contact |
KATHY LOWTHER |
Correspondent |
WELCH ALLYN, INC. |
4619 JORDAN RD. |
SKANEATELES FALLS,
NY
13153 -0187
|
|
Correspondent Contact |
KATHY LOWTHER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/26/1998 |
Decision Date | 02/27/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|