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U.S. Department of Health and Human Services

Product Classification

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Device needle, conduction, anesthetic (w/wo introducer)
Regulation Description Anesthesia conduction needle.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBSP
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5150
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons
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