Device Classification Name |
rongeur, cystoscopic, hot
|
510(k) Number |
K914934 |
Device Name |
HAND PACK |
Applicant |
WESTMARK HOSPITAL SUPPLIES |
1253 RAMONA SE |
GRAND RAPIDS,
MI
49507
|
|
Applicant Contact |
MARJORIE L SCHMIDT |
Correspondent |
WESTMARK HOSPITAL SUPPLIES |
1253 RAMONA SE |
GRAND RAPIDS,
MI
49507
|
|
Correspondent Contact |
MARJORIE L SCHMIDT |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/04/1991 |
Decision Date | 01/21/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|