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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K212328
Device Name DiscCath Needle Set
Applicant
Disccath, LLC
62 E 88th St.
New York,  NY  10128
Applicant Contact Gregory E. Lutz
Correspondent
Disccath, LLC
62 E 88th St.
New York,  NY  10128
Correspondent Contact Gregory E. Lutz
Regulation Number868.5150
Classification Product Code
BSP  
Date Received07/27/2021
Decision Date 09/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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