FDA.reportPublic FDA data

510(k) K802060

Device
STERILE TONSIL SPONGES
Applicant
MEDSPEC CORP.
510(k) number
K802060
Product code
GDY  
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-10
Date received
1980-08-25
Regulation
878.4450
Classification name
Gauze/sponge, Internal, X-ray Detectable
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.1997-12-17
K960236CPR LAP SPONGESCustom Pack Reliability1996-03-28
K955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.1996-02-22
K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.1995-12-19
K953830KENSORBKentron Health Care, Inc.1995-10-03
K953057CYLINDRICAL SPONGEMedical Perspectives Corp.1995-09-14
K953058ROUND STICK SPONGES, FLAT STICK SPONGESMedical Perspectives Corp.1995-09-14
K953059KITTNER DISSECTORMedical Perspectives Corp.1995-09-14
K953060ROSEBUD DISSECTORMedical Perspectives Corp.1995-09-14
K953062CHERRY DISSECTORMedical Perspectives Corp.1995-09-14
K953087CHERRY PIT DISSECTORMedical Perspectives Corp.1995-09-14
K953088TRIANGULAR SPONGESMedical Perspectives Corp.1995-09-14
K951911GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)Commercial Resources New Mexico, Ltd.1995-06-21
K950370ULTRACELL ORTHOPEDIC SPONGESUltracell Medical Technologies, Inc.1995-04-17
K950372ULTRACELL ORTHOPEDIC SPONGESUltracell Medical Technologies, Inc.1995-04-17

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