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, Nasopharyngeal
510(k) Number K911784
Device Name NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY
Applicant
North American Sterilization & Packaging Co.
15 White Lake Rd.
P.O. Box 923
Sparta,  NJ  07871
Applicant Contact HARRY A SCHLAKMAN
Correspondent
North American Sterilization & Packaging Co.
15 White Lake Rd.
P.O. Box 923
Sparta,  NJ  07871
Correspondent Contact HARRY A SCHLAKMAN
Regulation Number868.5100
Classification Product Code
BTQ  
Date Received04/22/1991
Decision Date 09/23/1991
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
-
-