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 Suture, Absorbable, Natural
510(k) Number K993695
Device Name LIGA-LOOP SUTURE APPLICATOR
Applicant
Hysterx, Inc.
18732 Saginaw
Irvine,  CA  92612
Applicant Contact JUDY F GORDON
Correspondent
Hysterx, Inc.
18732 Saginaw
Irvine,  CA  92612
Correspondent Contact JUDY F GORDON
Regulation Number878.4830
Classification Product Code
GAL  
Subsequent Product Codes
GAM   GAP   GEA  
Date Received11/02/1999
Decision Date 04/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-