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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Use Blood Lancet For Single Patient Use Only
510(k) Number K220633
Device Name MICROLET NEXT lancing device, MICROLET Lancet
Applicant
Ascensia Diabetes Care U.S., Inc.
5 Wood Hollow Rd.
Parsippany,  NJ  07054
Applicant Contact Sangram Yadav
Correspondent
Ascensia Diabetes Care U.S., Inc.
5 Wood Hollow Rd.
Parsippany,  NJ  07054
Correspondent Contact Sangram Yadav
Regulation Number878.4850
Classification Product Code
QRL  
Date Received03/04/2022
Decision Date 06/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02606838
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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