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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, sharps
510(k) Number K211464
Device Name Nitta M&T Safety Box
Applicant
Nitta M&T (Thailand) Co., Ltd.
19/52 Unit G5, Phaholyothin Rd., Moo 10 Khlong Nueng
Khlong Luang,  TH 12120
Applicant Contact Takumi Moro
Correspondent
mdi Consultants Inc.
55 Northern Blvd, Suite 200
Great Neck,  NY  11021
Correspondent Contact Vaibhav Rajal
Regulation Number880.5570
Classification Product Code
MMK  
Date Received05/11/2021
Decision Date 09/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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