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 Single-Use Reprocessed Ultrasonic Surgical Instruments
510(k) Number K193563
Device Name Medline ReNewal Reprocessed Harmonic ACE+7 Shears
Applicant
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
1500 NE Hemlock Ave.
Redmond,  OR  97756
Applicant Contact Gail Gassner
Correspondent
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
1500 NE Hemlock Ave.
Redmond,  OR  97756
Correspondent Contact Gail Gassner
Classification Product Code
NLQ  
Subsequent Product Code
LFL  
Date Received12/23/2019
Decision Date 08/19/2020
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-