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 K853665
Device Name SPLASH ADAPTOR
Applicant
OHIO MEDICAL RESEARCH, INC.
4353 MONROE ST.
TOLEDO,  OH  43606
Applicant Contact ROBERT E DUNLAP
Correspondent
OHIO MEDICAL RESEARCH, INC.
4353 MONROE ST.
TOLEDO,  OH  43606
Correspondent Contact ROBERT E DUNLAP
Regulation Number868.5995
Classification Product Code
BYH  
Date Received09/03/1985
Decision Date 10/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-