Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K882270 |
Device Name |
MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
10111 W. JEFFERSON BLVD. |
CULVER CITY,
CA
90232 -3578
|
|
Applicant Contact |
ROBERT R GIORGINI |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
10111 W. JEFFERSON BLVD. |
CULVER CITY,
CA
90232 -3578
|
|
Correspondent Contact |
ROBERT R GIORGINI |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 05/31/1988 |
Decision Date | 10/20/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|