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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K221206
Device Name Compass Steerable Needle
Applicant
Serpex Medical, Inc.
3350 Scott Blvd, Suite 37B
Santa Clara,  CA  95054
Applicant Contact Sasha Schrode
Correspondent
Honkanen Consulting, Inc.
738 Saddle Wood Drive
Eagan,  MN  55123
Correspondent Contact Laurie Lewandowski
Regulation Number874.4680
Classification Product Code
KTI  
Date Received04/26/2022
Decision Date 08/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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