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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
DiscCath LLC
62 E 88th Street
New York,  NY  10128
Applicant Contact Gregory E. Lutz
DiscCath LLC
62 E 88th Street
New York,  NY  10128
Correspondent Contact Gregory E. Lutz
Regulation Number868.5150
Classification Product Code
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