• 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 Device, Surgical, Cryogenic
510(k) Number K781302
Device Name NEUROSTAT, LLOYD
Applicant
SPEMBLY MEDICAL LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SPEMBLY MEDICAL LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number882.4250
Classification Product Code
GXH  
Date Received07/28/1978
Decision Date 08/15/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-