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 Clamp, Vascular
510(k) Number K970027
Device Name FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005
Applicant
Rmds, Inc.
1208 SE 104th Ave.
Vancouver,  WA  98664 -4740
Applicant Contact DELBERT L RICE
Correspondent
Rmds, Inc.
1208 SE 104th Ave.
Vancouver,  WA  98664 -4740
Correspondent Contact DELBERT L RICE
Regulation Number870.4450
Classification Product Code
DXC  
Date Received01/03/1997
Decision Date 08/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-