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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tympanostomy
510(k) Number K221254
Device Name Hummingbird Tympanostomy Tube System
Applicant
Preceptis Medical, Inc.
10900 89th Avenue North, Suite 4
Maple Grove,  MN  55369
Applicant Contact Steve Anderson
Correspondent
Preceptis Medical, Inc.
10900 89th Avenue North, Suite 4
Maple Grove,  MN  55369
Correspondent Contact Steve Anderson
Regulation Number874.3880
Classification Product Code
ETD  
Date Received05/02/2022
Decision Date 07/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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