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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K232831
Device Name Quiver Aspiration Pump
Applicant
Anoxia Medical, Inc.
3475 Investment Blvd., Suite #9
Hayward,  CA  94545
Applicant Contact Henry Nita
Correspondent
ProMedoss, Inc.
3521 Hatwynn Rd.
Charlott,  NC  28269
Correspondent Contact Bosmat Friedman-Cox
Regulation Number878.4780
Classification Product Code
BTA  
Subsequent Product Code
JCX  
Date Received09/13/2023
Decision Date 02/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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