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 Weights, Eyelid, External
510(k) Number K021750
Device Name LID CHAIN EYELID WEIGHTS
Applicant
Jedmed Instrument Co.
5416 Jedmed Ct.
Saint Louis,  MO  63129
Applicant Contact CRAIG R PARKS
Correspondent
Jedmed Instrument Co.
5416 Jedmed Ct.
Saint Louis,  MO  63129
Correspondent Contact CRAIG R PARKS
Regulation Number886.5700
Classification Product Code
MML  
Date Received05/28/2002
Decision Date 01/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-