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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Polymer Patient Examination Glove
510(k) Number K212586
Device Name Amazing+
Applicant
Amazing Rubber Products Pvt Ltd
Plot No 14c, Cochin Special Economic Zone
Cochin,  IN 682037
Applicant Contact Jayasankar S
Correspondent
Liberty Management Group Ltd.
75 Executive Dr, STE 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/16/2021
Decision Date 02/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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