HEMC BRAND Locking Bone Plates And Screws Osteosynthesis Plating System

Plate, Fixation, Bone

Hospital Equipment Manufacturing Company

The following data is part of a premarket notification filed by Hospital Equipment Manufacturing Company with the FDA for Hemc Brand Locking Bone Plates And Screws Osteosynthesis Plating System.

Pre-market Notification Details

Device IDK222282
510k NumberK222282
Device Name:HEMC BRAND Locking Bone Plates And Screws Osteosynthesis Plating System
ClassificationPlate, Fixation, Bone
Applicant Hospital Equipment Manufacturing Company A19/A20, Sector 7 Noida,  IN 201301
ContactHimanshu Sachdeva
CorrespondentHimanshu Sachdeva
Hospital Equipment Manufacturing Company A19/A20, Sector 7 Noida,  IN 201301
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-29
Decision Date2022-10-27

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