• 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 K915491
Device Name CURELLE
Applicant
BIOTEQUE CORP.
5` RAINLILY RD.
LEVITTOWN,  PA  19056
Applicant Contact DENIS DORSEY
Correspondent
BIOTEQUE CORP.
5` RAINLILY RD.
LEVITTOWN,  PA  19056
Correspondent Contact DENIS DORSEY
Regulation Number884.1175
Classification Product Code
HHK  
Date Received12/06/1991
Decision Date 11/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-