Name: Predicase
Price: 199 USD

K-number	K250586
Device name	Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
Applicant	Deroyal Industries, Inc.
Product code	OMP
Device class	Class II
Decision date	Nov 21, 2025
Decision	Substantially Equivalent
Regulation	878.4780

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory

Everything you need for a 510(k) submission. Nothing you don't.