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 System, Suction, Lipoplasty For Removal
510(k) Number K171286
Device Name PAL Multi-Use Cannulas and PAL Manual Wand
Applicant
Microaire Surgical Instruments, LLC
3590 Grans Forks Blvd.
Charlottesville,  VA  22911
Applicant Contact Glenn Gerstenfeld
Correspondent
Barile & Associates, Inc.
P.O. Box 5199
Clinton,  NJ  08809
Correspondent Contact Diane Sudduth
Regulation Number878.5040
Classification Product Code
QPB  
Date Received05/01/2017
Decision Date 10/13/2017
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
-
-