FDA.reportPublic FDA data

510(k) K903002

Device
PROBET (TM)
Applicant
GYNOPHARMA, INC.
510(k) number
K903002
Product code
HFF  
Decision
Substantially Equivalent (SESE)
Decision date
1991-04-05
Date received
1990-07-09
Regulation
884.1060
Classification name
Aspirator, Endometrial
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEVI ELLIS
Address
C/O Ellis Pharm Consulting Inc 913 State Rd. Princeton NJ US 08540 08540

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K041237ECHOSAMPLERGynetics Medical Products NV2004-09-08
K902693WALLACH FLEXIBLE ENDOMETRIAL SAMPLERWallach Surgical Devices, Inc.1991-01-31
K831212ENDOSCANNAxcan Scientific Corp.1984-06-15
K820641ACCURETTEAxcan Scientific Corp.1982-06-22

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases