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 Bur, Surgical, General & Plastic Surgery
510(k) Number K950449
Device Name SURGICAL BUR
Applicant
TRANSIDYNE GENERAL CORP.
400 HERALD JOURNAL PARK
SPARTANBURG,  SC  29303
Applicant Contact STEVEN W BUTLER
Correspondent
TRANSIDYNE GENERAL CORP.
400 HERALD JOURNAL PARK
SPARTANBURG,  SC  29303
Correspondent Contact STEVEN W BUTLER
Regulation Number878.4820
Classification Product Code
GFF  
Date Received02/03/1995
Decision Date 03/01/1995
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
-
-