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 Motor, Surgical Instrument, Pneumatic Powered
510(k) Number K952463
Device Name GS & GS20 SURGICAL TOOL SYSTEM
Applicant
Midas Rex Pneumatic Tools, Inc.
3001 Race St.
Fort Worth,  TX  76111 -4117
Applicant Contact FOREST BARBER, JR.
Correspondent
Midas Rex Pneumatic Tools, Inc.
3001 Race St.
Fort Worth,  TX  76111 -4117
Correspondent Contact FOREST BARBER, JR.
Regulation Number878.4820
Classification Product Code
GET  
Date Received05/26/1995
Decision Date 07/17/1995
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
Recalls CDRH Recalls
-
-