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510(k) Premarket Notification Database

Device Classification Name:	PURIFICATION SYSTEM, WATER
Regulation Number:	876.5665 [See Other Products with this regulation number]
510(k) Number:	K030652
Device Name:	MEDRO SPD
Applicant:	U.S. FILTER/IONPURE, INC. 10 TECHNOLOGY DR. LOWELL, MA 01851
Contact:	ROBERT DUDEK
Product Code:	FIP [See Other Manufacturers that make this Product]
Date Received:	02-28-2003
Decision Date:	09-03-2003
Decision:	SE
Advisory Committee:	GU
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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