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 nasopharyngoscope (flexible or rigid)
510(k) Number K152531
Device Name InstaClear Lens Cleaner
Applicant
GYRUS ACMI, INC.
136 TURNPIKE ROAD
SOUTHBOROUGH,  MA  01772
Applicant Contact DOLAN MILLS
Correspondent
GYRUS ACMI, INC.
136 TURNPIKE ROAD
SOUTHBOROUGH,  MA  01772
Correspondent Contact DOLAN MILLS
Regulation Number874.4760
Classification Product Code
EOB  
Date Received09/03/2015
Decision Date 01/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-