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 endoilluminator
510(k) Number K151604
Device Name 23ga Chandelier Illuminator, 25ga Chandelier Illuminator
Applicant
PEREGRINE SURGICAL LTD.
51 BRITAIN DRIVE
NEW BRITAIN,  PA  18901
Applicant Contact RYAN O'LEARY
Correspondent
PEREGRINE SURGICAL LTD.
51 BRITAIN DRIVE
NEW BRITAIN,  PA  18901
Correspondent Contact RYAN O'LEARY
Regulation Number876.1500
Classification Product Code
MPA  
Date Received06/15/2015
Decision Date 09/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-