• 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 Tube, Tracheostomy (W/Wo Connector)
510(k) Number K843785
Device Name WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR
Applicant
INTL. MEDICAL DEVICES LTD.
19205 PARTHENIA
SUITE J
NORTHRIDGE,  CA  91324 -
Applicant Contact MARCIA WEISS
Correspondent
INTL. MEDICAL DEVICES LTD.
19205 PARTHENIA
SUITE J
NORTHRIDGE,  CA  91324 -
Correspondent Contact MARCIA WEISS
Regulation Number868.5800
Classification Product Code
BTO  
Date Received09/27/1984
Decision Date 10/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-