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 Drills, Burrs, Trephines & Accessories (Manual)
510(k) Number K902818
Device Name MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT
Applicant
RUGGLES CORP.
38 BILLINGS RD.
NO. QUINCY,  MA  02171
Applicant Contact ALAN RUGGLES
Correspondent
RUGGLES CORP.
38 BILLINGS RD.
NO. QUINCY,  MA  02171
Correspondent Contact ALAN RUGGLES
Regulation Number882.4300
Classification Product Code
HBG  
Date Received06/27/1990
Decision Date 09/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-