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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Counter-Pulsating, External
510(k) Number K250756
Device Name Pression Wave PRO External Counter-Pulsation System
Applicant
Pression, Inc.
190 W. Lincoln Highway
Coatesville,  PA  19320
Applicant Contact Adam Salamon
Correspondent
Broderick Regulatory Consulting, LLC
7 Kendall St.
Winchester,  MA  01890
Correspondent Contact Julie Broderick
Regulation Number870.5225
Classification Product Code
DRN  
Date Received03/12/2025
Decision Date 12/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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