• 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 K970721
Device Name DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
Applicant
JOHNSON & JOHNSON MEDICAL, INC.
2500 E. ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON,  TX  76004 -3130
Applicant Contact WILLIAM P ROBB
Correspondent
JOHNSON & JOHNSON MEDICAL, INC.
2500 E. ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON,  TX  76004 -3130
Correspondent Contact WILLIAM P ROBB
Regulation Number880.5075
Classification Product Code
MCY  
Date Received02/27/1997
Decision Date 03/21/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-