Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K210107
Device Name Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
Applicant
Genadyne Biotechnologies, Inc.
16 Midland Ave.
Hicksville,  NY  11801
Applicant Contact Saiken Ho
Correspondent
Genadyne Biotechnologies, Inc.
16 Midland Ave.
Hicksville,  NY  11801
Correspondent Contact Saiken Ho
Regulation Number878.4780
Classification Product Code
OMP  
Date Received01/15/2021
Decision Date 06/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-