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 Sleeve, Limb, Compressible
510(k) Number K942664
Device Name KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM
Applicant
The Kendal Co.
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact DEAN E CIPORKIN
Correspondent
The Kendal Co.
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact DEAN E CIPORKIN
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/06/1994
Decision Date 01/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-