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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 Powered Suction Pump
510(k) Number K230233
Device Name Prospera Spectruum Negative Pressure Wound Therapy System
Applicant
Deroyal Industries, Inc.
200 Debusk Lane
Powell,  TN  37849
Applicant Contact Mary Catherine Reeves
Correspondent
Deroyal Industries, Inc.
200 Debusk Lane
Powell,  TN  37849
Correspondent Contact Mary Catherine Reeves
Regulation Number878.4780
Classification Product Code
OMP  
Date Received01/27/2023
Decision Date 04/18/2024
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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