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Device
catheter, balloon for retinal reattachment
Review Panel
Ophthalmic
Product Code
LOG
Premarket Review
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices (DHT1A)
Submission Type
PMA
Device Class
3
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
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