Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K952889 |
Device Name |
INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS |
Applicant |
MATERIALS CONVERSION CORP. |
236-B EGIDI DR. |
WHEELING,
IL
60090
|
|
Applicant Contact |
MICHAEL HENDERSON |
Correspondent |
MATERIALS CONVERSION CORP. |
236-B EGIDI DR. |
WHEELING,
IL
60090
|
|
Correspondent Contact |
MICHAEL HENDERSON |
Regulation Number | 884.1720
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/23/1995 |
Decision Date | 12/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|