JAIN SUTURE/VESIBAND ORGANIZER

Instrument, Manual, Surgical, General Use

JAIN SURGICAL EQUIPMENT, INC.

The following data is part of a premarket notification filed by Jain Surgical Equipment, Inc. with the FDA for Jain Suture/vesiband Organizer.

Pre-market Notification Details

Device IDK905105
510k NumberK905105
Device Name:JAIN SUTURE/VESIBAND ORGANIZER
ClassificationInstrument, Manual, Surgical, General Use
Applicant JAIN SURGICAL EQUIPMENT, INC. 7829 SPRINKLE RD. Kalamazoo,  MI  49001
ContactMelisa Root
CorrespondentMelisa Root
JAIN SURGICAL EQUIPMENT, INC. 7829 SPRINKLE RD. Kalamazoo,  MI  49001
Product CodeMDM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-13
Decision Date1991-01-31

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