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 K960310
Device Name EPIC INTRODUCER SHEATH
Applicant
North American Instrument Corp.
Pruyns Island Rd.
Glens Falls,  NY  12801
Applicant Contact MARY MEAGHER-RUBIN
Correspondent
North American Instrument Corp.
Pruyns Island Rd.
Glens Falls,  NY  12801
Correspondent Contact MARY MEAGHER-RUBIN
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/22/1996
Decision Date 02/07/1996
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
-
-