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, nonabsorbable, synthetic, polypropylene
510(k) Number K926588
Device Name REVISED LABELING FOR POLYPROPYLENE SUTURE
Applicant
LOOK, INC.
2020 LONNIE ABBOTT IND. BLVD.
ADA,  OK  74820
Applicant Contact GARY AINSWORTH
Correspondent
LOOK, INC.
2020 LONNIE ABBOTT IND. BLVD.
ADA,  OK  74820
Correspondent Contact GARY AINSWORTH
Regulation Number878.5010
Classification Product Code
GAW  
Date Received12/01/1992
Decision Date 12/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-