510(k) K992785

IBC FLOGUARD, MODEL 6050 by International Biophysics Corp. — Product Code MJJ

K992785 is an FDA 510(k) premarket notification submitted by International Biophysics Corp. for the device "IBC FLOGUARD, MODEL 6050". The FDA issued a decision of Substantially Equivalent on January 14, 2000. The device falls under product code MJJ (Cpb Check Valve, Retrograde Flow, In-Line), a Class II device regulated under 21 CFR 870.4400. International Biophysics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2000
Date Received
August 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cpb Check Valve, Retrograde Flow, In-Line
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type