510(k) K945559

MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS by Mar Cor Services, Inc. — Product Code FIP

K945559 is an FDA 510(k) premarket notification submitted by Mar Cor Services, Inc. for the device "MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS". The FDA issued a decision of Substantially Equivalent on May 28, 1996. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Mar Cor Services, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1996
Date Received
November 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type