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 (Compound, Powered)
510(k) Number K933894
Device Name DISPOSABLE PERFORATOR
Applicant
Codman & Shurtleff, Inc.
41 PACELLA PARK DR.
RANDOLPH INDUSTRIAL PARK
RANDOLPH,  MA  02368 -1794
Applicant Contact AMY WALTERS
Correspondent
Codman & Shurtleff, Inc.
41 PACELLA PARK DR.
RANDOLPH INDUSTRIAL PARK
RANDOLPH,  MA  02368 -1794
Correspondent Contact AMY WALTERS
Regulation Number882.4305
Classification Product Code
HBF  
Date Received08/10/1993
Decision Date 12/10/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-