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 table, obstetric (and accessories)
510(k) Number K864194
Device Name PALMER OBSTETRIC BRACE
Applicant
AD-TECH MEDICAL INSTRUMENT CORP.
1901 WILLIAM ST.
RACINE,  WI  53404 -1876
Applicant Contact DAVID A PUTZ
Correspondent
AD-TECH MEDICAL INSTRUMENT CORP.
1901 WILLIAM ST.
RACINE,  WI  53404 -1876
Correspondent Contact DAVID A PUTZ
Regulation Number884.4900
Classification Product Code
KNC  
Date Received10/27/1986
Decision Date 01/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-