• 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 Motor, Surgical Instrument, Ac-Powered
510(k) Number K951118
Device Name 3M MAXI-DRIVER II ELECTRIC SYSTEM
Applicant
3M Company
4320 Vanowen St.
Burbank,  CA  91505
Applicant Contact WILLARD LARSON
Correspondent
3M Company
4320 Vanowen St.
Burbank,  CA  91505
Correspondent Contact WILLARD LARSON
Regulation Number878.4820
Classification Product Code
GEY  
Date Received03/10/1995
Decision Date 07/06/1995
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
-
-