Device Classification Name |
Labware, Assisted Reproduction
|
510(k) Number |
K122982 |
Device Name |
CRYOLOCK |
Applicant |
BIOTECH, INC. |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
ROBYN SCOPIS |
Correspondent |
BIOTECH, INC. |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
ROBYN SCOPIS |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 09/26/2012 |
Decision Date | 01/09/2014 |
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
|
|
|