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 Speculum, Ent
510(k) Number K853588
Device Name FIBRELIGHT NASAL SPECULA
Applicant
Downs Surgical , Ltd.
42 Industrial Way
Wilmington,  MA  01887
Applicant Contact JARVIS CRIBB
Correspondent
Downs Surgical , Ltd.
42 Industrial Way
Wilmington,  MA  01887
Correspondent Contact JARVIS CRIBB
Regulation Number878.1800
Classification Product Code
EPY  
Date Received08/27/1985
Decision Date 12/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-