Device |
device, fertility diagnostic, proceptive |
Review Panel |
Obstetrics/Gynecology |
Product Code | LHD |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Unclassified Reason
|
Pre-Amendment
|
Submission Type |
Enforcement Discretion
|
Device Class |
Unclassified
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|