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 Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
510(k) Number K930785
Device Name THE DE SOUTTER M182 DRILL
Applicant
De Soutter Medical, Ltd.
Unit 1 Kings Park
Primrose Hill
Kings Langley Herts,  GB WD4 8ST
Applicant Contact BERNARD GRATWICKE
Correspondent
De Soutter Medical, Ltd.
Unit 1 Kings Park
Primrose Hill
Kings Langley Herts,  GB WD4 8ST
Correspondent Contact BERNARD GRATWICKE
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received02/16/1993
Decision Date 10/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-