Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K932796 |
Device Name |
OWENS TROCAR |
Applicant |
OWENS INDUSTRIES, INC. |
7815 S. 6TH ST. |
OAK CREEK,
WI
53154
|
|
Applicant Contact |
TERRENCE R SHORE |
Correspondent |
OWENS INDUSTRIES, INC. |
7815 S. 6TH ST. |
OAK CREEK,
WI
53154
|
|
Correspondent Contact |
TERRENCE R SHORE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/09/1993 |
Decision Date | 02/02/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|