510(k) K972703

REDYROB-CLOSED WOUND DRAINAGE SYSTEM by B.Braun Medical, Inc. — Product Code GCY

K972703 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "REDYROB-CLOSED WOUND DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 1, 1997. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1997
Date Received
July 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
Review Panel
SU
Submission Type