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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Patient Isolation
510(k) Number K231256
Device Name Carecube Negative Pressure Isolation Chamber
Applicant
Carecubes, Inc.
3101 20th St.
San Francisco,  CA  94110
Applicant Contact Alexander Laskey
Correspondent
Carecubes, Inc.
300 Oxford Dr., Suite 330
Monroeville,  PA  15146
Correspondent Contact Steve Bollinger
Regulation Number880.5450
Classification Product Code
LGM  
Date Received05/01/2023
Decision Date 01/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Clinical Trials NCT05468723
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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