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 Drain, Tee (Water Trap)
510(k) Number K881790
Device Name SAFETY DRAIN
Applicant
Ballard Medical Products
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact ERNEST CHAMBERLAIN
Correspondent
Ballard Medical Products
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact ERNEST CHAMBERLAIN
Regulation Number868.5995
Classification Product Code
BYH  
Date Received04/26/1988
Decision Date 06/21/1988
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
-
-