Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K964123 |
Device Name |
REUSABLE TROCAR WITH SLEEVE (COMMON) |
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 | 876.1500
|
Classification Product Code |
|
Date Received | 10/15/1996 |
Decision Date | 12/12/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|