REDYROB-CLOSED WOUND DRAINAGE SYSTEM

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Redyrob-closed Wound Drainage System.

Pre-market Notification Details

Device IDK972703
510k NumberK972703
Device Name:REDYROB-CLOSED WOUND DRAINAGE SYSTEM
ClassificationApparatus, Suction, Single Patient Use, Portable, Nonpowered
Applicant B. BRAUN MEDICAL, INC. 824 12TH AVE. Bethlehem,  PA  18018
ContactMark S Alsberge
CorrespondentMark S Alsberge
B. BRAUN MEDICAL, INC. 824 12TH AVE. Bethlehem,  PA  18018
Product CodeGCY  
CFR Regulation Number878.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-18
Decision Date1997-10-01
Summary:summary

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