JAIN BLOOD SHIELD

Catheter And Tip, Suction

JAIN SURGICAL EQUIPMENT, INC.

The following data is part of a premarket notification filed by Jain Surgical Equipment, Inc. with the FDA for Jain Blood Shield.

Pre-market Notification Details

Device IDK913896
510k NumberK913896
Device Name:JAIN BLOOD SHIELD
ClassificationCatheter And Tip, Suction
Applicant JAIN SURGICAL EQUIPMENT, INC. 7829 SPRINKLE RD. Kalamazoo,  MI  49001
ContactMelisa M Root
CorrespondentMelisa M Root
JAIN SURGICAL EQUIPMENT, INC. 7829 SPRINKLE RD. Kalamazoo,  MI  49001
Product CodeJOL  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-30
Decision Date1992-03-06

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