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510(k) K011488

Device
SPIRABRUSH CX BIOPSY INSTRUMENT
Applicant
TRYLON CORP.
510(k) number
K011488
Product code
HFB  
Decision
Substantially Equivalent (SESE)
Decision date
2002-02-22
Date received
2001-05-15
Regulation
884.4530
Classification name
Forceps, Biopsy, Gynecological
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARTIN LONKY
Address
970 W. 190th St., Suite 850 Torrance CA US 90502 90502

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HFB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944444CIT BIOPSY PUNCHESChirurgische Instrumente1995-09-29
K930773SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPSSymbiosis Corp.1994-07-28
K933767FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSYMahe-Medizintechnik1994-05-26
K926595OWENS BIOPSY FORCEPSOwens Industries, Inc.1994-05-25
K926527ROTO FIT BIOPSY FORCEPSThomasville Medical Assoc.1994-02-25
K930036THOMAS MEDICAL BIOPSY FORCEPSThomasville Medical Assoc.1994-02-24
K926538TISCHLER BIOPSY FORCEPSThomasville Medical Assoc.1994-02-24
K924224OWENS BIOPSY FORCEPSOwens Precision Systems, Inc.1994-02-04
K902049CROAK OVARIAN BIOPSY FORCEPGynescope Corp.1990-06-07
K895303EVER-SHARP BIOPSY FORCEPSSouthwest Medical Mfg., Inc.1990-01-16
K891043ROTO FIT BIOPSY FORCEPSZinnanti Surgical Instruments, Inc.1989-03-22
K891034TISCHLER BIOPSY FORCEPSZinnanti Surgical Instruments, Inc.1989-03-17
K891027ZSI BIOPSY FORCEPSZinnanti Surgical Instruments, Inc.1989-03-17
K890380CERVICAL BIOPSY FORCEPSKinetic Medical Products1989-02-27
K852357GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIPGyneco, Inc.1985-07-05

Legacy Summary#

summary

FDA Review#

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