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 Wound Dressing Kit
510(k) Number K951476
Device Name E-PACK PROCEDURE KITS
Applicant
ETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Applicant Contact JOHN D PAULSON
Correspondent
ETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact JOHN D PAULSON
Regulation Number880.5075
Classification Product Code
MCY  
Date Received03/30/1995
Decision Date 05/23/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-