Device Classification Name |
electrocautery, gynecologic (and accessories)
|
510(k) Number |
K061651 |
Device Name |
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 |
Applicant |
APPLE MEDICAL CORP. |
28 LORD RD., UNIT 135 |
MARLBORO,
MA
01752
|
|
Applicant Contact |
JOHN C PULFORD |
Correspondent |
APPLE MEDICAL CORP. |
28 LORD RD., UNIT 135 |
MARLBORO,
MA
01752
|
|
Correspondent Contact |
JOHN C PULFORD |
Regulation Number | 884.4120
|
Classification Product Code |
|
Date Received | 06/13/2006 |
Decision Date | 10/20/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|