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 Transducer, Ultrasonic, Obstetric
510(k) Number K827885
Device Name BIO-DERM COUPLING LOTION
Applicant
Whs Products, Inc.
3312b S. Peoria
Tulsa,  OK  74105
Correspondent
Whs Products, Inc.
3312b S. Peoria
Tulsa,  OK  74105
Regulation Number884.2960
Classification Product Code
HGL  
Date Received01/01/1982
Decision Date 01/29/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-