• 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 laparoscope, gynecologic (and accessories)
510(k) Number K101458
FOIA Releasable 510(k) K101458
Device Name LINA XCISE MODEL MOR-1515
Applicant
LINA MEDICAL APS
1289 N. FORDHAM BLVD.
SUITE A-128
CHAPEL HILL,  NC  27517
Applicant Contact WALT BRITTLE
Correspondent
LINA MEDICAL APS
1289 N. FORDHAM BLVD.
SUITE A-128
CHAPEL HILL,  NC  27517
Correspondent Contact WALT BRITTLE
Regulation Number884.1720
Classification Product Code
HET  
Date Received05/26/2010
Decision Date 03/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-