OMNITECH SYSTEMS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18352411000518605OMNITECH SYSTEMS, INC.1N2020-04-25450 SOUTH CAMPBELL, SUITE 2 VALPARAISO IN US 46385

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
515541536599595K981464OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODEKNF1998-07-10
515542068849408K981463OMNITECH RESECTOSCOPE ROLLER ELECTRODEKNF1998-07-17
515541027814149K962538BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)FAS1996-12-17
515541919975772K961841BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)FAS1996-10-09
515541663800135K935874COOK COAGULATOR PROBEGEI1994-03-07
515541065311482K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeFAS2016-06-27
515541792568646K050454OMNITECH FULGURATING ELECTRODEFAS2005-05-27
515541090134227K040390STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEMHIH2004-05-17
515541683499526

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FAS42016-06-27
KNF21998-07-17
HIH12004-05-17
GEI11994-03-07

PMN#