Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K771964 |
Device Name |
8MM TROCAR & CANNUAL W/STOPCOCK |
Applicant |
KLI |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
KLI |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 10/17/1977 |
Decision Date | 10/25/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|