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U.S. Department of Health and Human Services

Product Classification
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Device inhaler, metered dose or dry powder, cder or cber led
Definition Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route
Physical State Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route
Technical Method Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route
Target Area Inhalation
Review Panel Anesthesiology
Product CodeQKS
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
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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