Device Classification Name |
detector, blood level
|
510(k) Number |
K952691 |
Device Name |
WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT |
Applicant |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
P.O. BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Applicant Contact |
MARY KAY TESORO |
Correspondent |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
P.O. BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Correspondent Contact |
MARY KAY TESORO |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 06/12/1995 |
Decision Date | 07/31/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|