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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Non-Powered Suction Apparatus
510(k) Number K212971
Device Name NPseal
Applicant
Guard Medical, Inc.
1221 Brickwell Ave., Suite 900
Miami,  FL  33131
Applicant Contact Machiel Van Der Leest
Correspondent
AlvaMed, Inc.
935 Great Plain Ave., Suite 166
Needham,  MA  02492
Correspondent Contact Eric Bannon
Regulation Number878.4683
Classification Product Code
OKO  
Date Received09/17/2021
Decision Date 02/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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