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 Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K931644
Device Name GERTIE MARX NEEDLE
Applicant
INTL. MEDICAL-DENTAL PRODUCTS USA, INC.
P.O. BOX 681180
528 PARK AVENUE
PARK CITY,  UT  84068
Applicant Contact WALTER ZOHMANN
Correspondent
INTL. MEDICAL-DENTAL PRODUCTS USA, INC.
P.O. BOX 681180
528 PARK AVENUE
PARK CITY,  UT  84068
Correspondent Contact WALTER ZOHMANN
Regulation Number868.5150
Classification Product Code
BSP  
Date Received04/02/1993
Decision Date 09/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-