510(k) K003877

MAR COR SERVICES SEMPER PURE RO MACHINE by Mar Cor Services, Inc. — Product Code FIP

K003877 is an FDA 510(k) premarket notification submitted by Mar Cor Services, Inc. for the device "MAR COR SERVICES SEMPER PURE RO MACHINE". The FDA issued a decision of Substantially Equivalent on June 22, 2001. 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
June 22, 2001
Date Received
December 15, 2000
Clearance Type
Abbreviated
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