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 Anesthesia Conduction Kit
510(k) Number K881429
Device Name YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.
Applicant
Medical Repackers Co.
P.O. Box 1500
Fort Payne,  AL  35967
Applicant Contact BILLY A HODGES
Correspondent
Medical Repackers Co.
P.O. Box 1500
Fort Payne,  AL  35967
Correspondent Contact BILLY A HODGES
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received03/29/1988
Decision Date 04/25/1988
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
-
-