Device Classification Name |
laparoscope, gynecologic (and accessories) |
||||
---|---|---|---|---|---|
510(k) Number | K960262 | ||||
Device Name | CORING MORCELLATOR | ||||
Applicant |
|
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Applicant Contact | tammy bacon | ||||
Correspondent |
|
||||
Correspodent Contact | tammy bacon | ||||
Regulation Number | 884.1720 | ||||
Classification Product Code |
|
||||
Date Received | 01/18/1996 | ||||
Decision Date | 04/15/1996 | ||||
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 |