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 amniotome
510(k) Number K871087
Device Name S.C.M.T. PERFORATOR
Applicant
SALT CREEK MEDICAL TECHNOLOGIES
5500 ARAPAHO PASS
PINCKNEY,  MI  48169
Applicant Contact HOWARD MEADE
Correspondent
SALT CREEK MEDICAL TECHNOLOGIES
5500 ARAPAHO PASS
PINCKNEY,  MI  48169
Correspondent Contact HOWARD MEADE
Regulation Number884.4530
Classification Product Code
HGE  
Date Received03/18/1987
Decision Date 03/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-