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 K892866
Device Name AUTOMATIC CRANIAL DRILL (PERFORATOR)
Applicant
Acra Cut, Inc.
989 Main St.
Acton,  MA  01720
Applicant Contact JOHN W BAKER
Correspondent
Acra Cut, Inc.
989 Main St.
Acton,  MA  01720
Correspondent Contact JOHN W BAKER
Regulation Number882.4305
Classification Product Code
HBF  
Date Received04/19/1989
Decision Date 06/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-