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 K923525
Device Name NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR
Applicant
Surgical Dynamics, Inc.
1240 S. Loop Rd.
Alameda,  CA  94501
Applicant Contact CHARMAINE HENDERSON
Correspondent
Surgical Dynamics, Inc.
1240 S. Loop Rd.
Alameda,  CA  94501
Correspondent Contact CHARMAINE HENDERSON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/16/1992
Decision Date 02/09/1993
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
-
-