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 photocoagulator and accessories
510(k) Number K122997
Device Name 23GA CURVED ILLUMINATING LASER PROBE
Applicant
PEREGRINE SURGICAL LTD.
51 BRITAIN DR.
NEW BRITAIN,  PA  18901
Applicant Contact RYAN O'LEARY
Correspondent
PEREGRINE SURGICAL LTD.
51 BRITAIN DR.
NEW BRITAIN,  PA  18901
Correspondent Contact RYAN O'LEARY
Regulation Number886.4690
Classification Product Code
HQB  
Subsequent Product Codes
HQF   MPA  
Date Received09/27/2012
Decision Date 06/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-