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 Magnet, Permanent
510(k) Number K880855
Device Name PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG
Applicant
RICHARD JAMES, INC.
P.O. BOX 309
LYNNFIELD,  MA  01940
Applicant Contact WAYNE A RICHARD
Correspondent
RICHARD JAMES, INC.
P.O. BOX 309
LYNNFIELD,  MA  01940
Correspondent Contact WAYNE A RICHARD
Regulation Number886.4445
Classification Product Code
HPN  
Date Received03/01/1988
Decision Date 04/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-