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 Rongeur
510(k) Number K874954
Device Name MANUAL RONGEUR
Applicant
Solway, Inc.
Post Office Box 7647
Hollywood,  FL  33081
Applicant Contact MARTIN MUNZER
Correspondent
Solway, Inc.
Post Office Box 7647
Hollywood,  FL  33081
Correspondent Contact MARTIN MUNZER
Regulation Number888.4540
Classification Product Code
HTX  
Date Received12/02/1987
Decision Date 12/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-