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 Introducer, Catheter
510(k) Number K903840
Device Name GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY
Applicant
Intec Medical, Inc.
P.O. Box 2186
35a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact KENNETH SPECTOR
Correspondent
Intec Medical, Inc.
P.O. Box 2186
35a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact KENNETH SPECTOR
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/21/1990
Decision Date 10/16/1990
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
-
-