Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K964450 |
Device Name |
SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT |
Applicant |
PILLING WECK GROUP |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Applicant Contact |
KARENANN J BROZOWSKI |
Correspondent |
PILLING WECK GROUP |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Correspondent Contact |
KARENANN J BROZOWSKI |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 11/06/1996 |
Decision Date | 01/10/1997 |
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
|
|
|