• 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 retractor, self-retaining, for neurosurgery
510(k) Number K882071
Device Name CRANK FRAME RETRACTOR
Applicant
KARLIN TECHNOLOGY, INC.
330 WASHINGTON ST.
SUITE 314
MARINA DEL REY,  CA  90292
Applicant Contact MARK WEIDHAAS
Correspondent
KARLIN TECHNOLOGY, INC.
330 WASHINGTON ST.
SUITE 314
MARINA DEL REY,  CA  90292
Correspondent Contact MARK WEIDHAAS
Regulation Number882.4800
Classification Product Code
GZT  
Date Received05/17/1988
Decision Date 06/10/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-