Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K200228 |
Device Name |
ClearCam System |
Applicant |
ClearCam, LLC |
1601 Trinity St., Bldg B M/S Z-1400 |
Austin,
TX
78712
|
|
Applicant Contact |
Chris Idelson |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/30/2020 |
Decision Date | 02/19/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|