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U.S. Department of Health and Human Services

Product Classification
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Device ophthalmic needle
Regulation Description Hypodermic single lumen needle.
Definition An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye.
Physical State sterile hypodermic needles
Technical Method An Ophthalmic Needle is to be used to inject fluids into or withdraw fluids from the eye.
Target Area The device is intended for injections into the eye.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQYM
Premarket Review Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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