• 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 Mesh, Surgical, Polymeric
510(k) Number K810428
FOIA Releasable 510(k) K810428
Device Name VICRYL
Applicant
ETHICON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ETHICON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/18/1981
Decision Date 03/13/1981
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
-
-