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 forceps, ophthalmic
510(k) Number K842697
Device Name ROOTMAN ORBITAL SURGERY INSTRUMENT SET
Applicant
DOWNS SURGICAL LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DOWNS SURGICAL LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.4350
Classification Product Code
HNR  
Date Received07/11/1984
Decision Date 08/07/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-