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U.S. Department of Health and Human Services

Product Classification
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Device nasal spray, systemic delivery, cder or cber led
Definition Nasal spray for systemic delivery of drug substance.
Physical State Nasal spray for systemic delivery of drug substance.
Technical Method Nasal spray for systemic delivery of drug substance.
Target Area Nasal spray for systemic delivery of drug substance.
Review Panel General Hospital
Product CodeQIY
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Not Classified Reason Unknown
Submission Type Contact ODE
Device Class Not Classified
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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