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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 K200305
Device Name NPseal
Applicant
Guard Medical, Inc.
10 E. 40th St., Suite 3310
New York,  NY  10016
Applicant Contact Machiel Van der Leest
Correspondent
AlvaMed, Inc.
935 Great Plain Ave.
#166
Needham,  MA  02492
Correspondent Contact Eric Bannon
Regulation Number878.4683
Classification Product Code
OKO  
Date Received02/06/2020
Decision Date 05/26/2020
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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