FDA.reportPublic FDA data

510(k) K801819

Device
SURGICAL INSTRUMENTS
Applicant
ROBERT I. CHIEN & ASSOC., INC.
510(k) number
K801819
Product code
HXD  
Decision
Substantially Equivalent (SESE)
Decision date
1980-08-20
Date received
1980-07-31
Regulation
878.4800
Classification name
Clamp
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 HXD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890368KIDNEY CLAMPKinetic Medical Products1989-02-03
K890371INTESTINAL CRUSHING CLAMPKinetic Medical Products1989-02-03
K890372INTESTINAL CLAMPKinetic Medical Products1989-02-03
K890381PARAMETRIUM CLAMPKinetic Medical Products1989-02-03
K874959VASCULAR CLAMPSolway, Inc.1987-12-30
K872386C CLAMPMed-Tool, Inc.1987-07-02
K863653SUCTION-OFFB&B Medical Technologies, Inc.1986-10-07
K853538CANNULA CLAMPCp Medical1985-09-12
K851654OMNIMED CLAMPOmni Intl., Inc.1985-05-31
K801028RICA OR SMIC SURGICAL INSTRUMENTSRobert I. Chien & Assoc., Inc.1980-05-20
K791289GIZMO TOWEL CLAMPHemoy, Inc.1979-07-24
K782090CLAMP, DISPOSABLEConcord Laboratories, Inc.1978-12-20
K770118CARPENTER BONE CLAMPStryker Corp.1977-01-26

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