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 K122905
Device Name PEREGRINE 23GA CURVED LASER PROBE
Applicant
PEREGRINE SURGICAL, LTD.
51 Britain Drive
Doylestown,  PA  18901
Applicant Contact RYAN O'LEARY
Correspondent
PEREGRINE SURGICAL, LTD.
51 Britain Drive
Doylestown,  PA  18901
Correspondent Contact RYAN O'LEARY
Regulation Number886.4690
Classification Product Code
HQB  
Date Received09/21/2012
Decision Date 04/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Special
Reviewed by Third Party No
Combination Product No
-
-