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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Non-Powered Suction Apparatus
510(k) Number K254160
Device Name VacHeal Negative Pressure Wound Therapy System
Applicant
VacHeal, LLC
40 E. Montgomery Ave.
4th Floor
Ardmore,  PA  19003
Applicant Contact Tiffany Morrison
Correspondent
VacHeal, LLC
40 E. Montgomery Ave.
4th Floor
Ardmore,  PA  19003
Correspondent Contact Tiffany Morrison
Regulation Number878.4683
Classification Product Code
OKO  
Date Received12/22/2025
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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