FDA.reportPublic FDA data

510(k) K902693

Device
WALLACH FLEXIBLE ENDOMETRIAL SAMPLER
Applicant
WALLACH SURGICAL DEVICES, INC.
510(k) number
K902693
Product code
HFF  
Decision
Substantially Equivalent (SESE)
Decision date
1991-01-31
Date received
1990-06-19
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
VINCENT FRAZZETTA
Address
291 Pepe'S Farm Rd. Milford CT US 06460 06460

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
K903002PROBET (TM)Gynopharma, Inc.1991-04-05
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