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 Airway, Oropharyngeal, Anesthesiology
510(k) Number K892123
Device Name GOETTINGER EMERGENCY RESUSCITATION TUBE
Applicant
Plastic Parts Corp.
213 Royal Palm Dr.
Fort Lauderdale,  FL  33301
Applicant Contact OLAF MITTELSTAEDT
Correspondent
Plastic Parts Corp.
213 Royal Palm Dr.
Fort Lauderdale,  FL  33301
Correspondent Contact OLAF MITTELSTAEDT
Regulation Number868.5110
Classification Product Code
CAE  
Date Received04/03/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-