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 K001625
Device Name PRONOVA NONABSORBABLE SUTURE, USP
Applicant
ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Applicant Contact PETER M CECCHINI
Correspondent
ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Correspondent Contact PETER M CECCHINI
Regulation Number878.5010
Classification Product Code
GAW  
Date Received05/17/2000
Decision Date 07/10/2000
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
-
-