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 Mouthpiece, Breathing
510(k) Number K865093
Device Name SAFE-T-SHIELD MOUTHPIECE
Applicant
Medi Nuclear Corp., Inc.
4501 Littlejohn St.
Baldwin Park,  CA  91706
Applicant Contact RUSSELL W KING
Correspondent
Medi Nuclear Corp., Inc.
4501 Littlejohn St.
Baldwin Park,  CA  91706
Correspondent Contact RUSSELL W KING
Regulation Number868.5620
Classification Product Code
BYP  
Date Received12/30/1986
Decision Date 01/15/1987
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
-
-