Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K915099 |
Device Name |
ENDOPATH ENDOS LINEAR CUT W/SAF LOCK-OUT/RELOAD UN |
Applicant |
ETHICON, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Applicant Contact |
SANDRA V DIGGS |
Correspondent |
ETHICON, INC. |
4545 CREEK RD. |
CINCINNATI,
OH
45242 -2839
|
|
Correspondent Contact |
SANDRA V DIGGS |
Regulation Number | 876.1500 |
Classification Product Code |
|
Date Received | 11/12/1991 |
Decision Date | 03/19/1992 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|