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 apparatus, suction, single patient use, portable, nonpowered
510(k) Number K863482
Device Name DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE
Applicant
CARDIO METRICS, INC.
10415 LANDSBURY DR.
HOUSTON,  TX  77099
Applicant Contact CATHY SPILLER
Correspondent
CARDIO METRICS, INC.
10415 LANDSBURY DR.
HOUSTON,  TX  77099
Correspondent Contact CATHY SPILLER
Regulation Number878.4680
Classification Product Code
GCY  
Date Received09/09/1986
Decision Date 10/14/1986
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
-
-