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 K862788
Device Name MP-4400 MOUTHPIECE-FLANGE SEAL
Applicant
MEDIPART JERRY ALEXANDER
607 SPRING BEACH RD.
CARY,  IL  60013
Applicant Contact JERRY ALEXANDER
Correspondent
MEDIPART JERRY ALEXANDER
607 SPRING BEACH RD.
CARY,  IL  60013
Correspondent Contact JERRY ALEXANDER
Regulation Number868.5620
Classification Product Code
BYP  
Date Received07/23/1986
Decision Date 08/01/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-