• 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 instrument, microsurgical
510(k) Number K873933
Device Name RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM
Applicant
DOWNS SURGICAL LTD.
42 industrial way
wilmington,  MA  01887
Applicant Contact mr. j forster
Correspondent
DOWNS SURGICAL LTD.
42 industrial way
wilmington,  MA  01887
Correspondent Contact mr. j forster
Regulation Number882.4525
Classification Product Code
GZX  
Date Received09/25/1987
Decision Date 12/17/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-