Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K973543 |
Device Name |
KRONNER LOW PROFILE SCOPE HOLDER |
Applicant |
KRONNER PROTOTYPES, INC. |
1443 UPPER CLEVELAND RAPIDS RD |
ROSEBURG,
OR
97470
|
|
Applicant Contact |
CRYSTAL KRONNER |
Correspondent |
KRONNER PROTOTYPES, INC. |
1443 UPPER CLEVELAND RAPIDS RD |
ROSEBURG,
OR
97470
|
|
Correspondent Contact |
CRYSTAL KRONNER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/18/1997 |
Decision Date | 01/12/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|