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 Arthroscope
510(k) Number K060172
Device Name REMA SHAVER BLADES
Applicant
Rema Medizintechnik GmbH.
731-733 Shotgun Rd.
Ft. Lauderdale,  FL  33326
Applicant Contact GERALD GOIGITZER
Correspondent
Rema Medizintechnik GmbH.
731-733 Shotgun Rd.
Ft. Lauderdale,  FL  33326
Correspondent Contact GERALD GOIGITZER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/23/2006
Decision Date 05/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-