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 Saw, Powered, And Accessories
510(k) Number K935517
Device Name SNAP STERNUM SAW
Applicant
Surgiquip, Inc.
Regulatory Consultants
18665 Midway Rd., Number 521
Dallas,  TX  75287
Applicant Contact MARY BIGGERS
Correspondent
Surgiquip, Inc.
Regulatory Consultants
18665 Midway Rd., Number 521
Dallas,  TX  75287
Correspondent Contact MARY BIGGERS
Regulation Number878.4820
Classification Product Code
HAB  
Date Received11/18/1993
Decision Date 03/10/1994
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
-
-