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 patch, pledget and intracardiac, petp, ptfe, polypropylene
510(k) Number K905073
Device Name CARDIOVASCULAR REPAIR PATCH
Applicant
IMPRA, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE,  AZ  85281
Applicant Contact RAJAGOPAL R KOWLIGI
Correspondent
IMPRA, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE,  AZ  85281
Correspondent Contact RAJAGOPAL R KOWLIGI
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received11/09/1990
Decision Date 12/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-