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 Curette, Suction, Endometrial (And Accessories)
510(k) Number K000026
Device Name APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
Applicant
Apple Medical Corp.
28 Lord Rd., Unit 135
Marlboro,  MA  01752
Applicant Contact JOHN PULFORD
Correspondent
Apple Medical Corp.
28 Lord Rd., Unit 135
Marlboro,  MA  01752
Correspondent Contact JOHN PULFORD
Regulation Number884.1175
Classification Product Code
HHK  
Date Received01/05/2000
Decision Date 03/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-