FDA.reportPublic FDA data

510(k) K864897

Device
DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
Applicant
DALE MEDICAL PRODUCTS, INC.
510(k) number
K864897
Product code
GAX  
Decision
Substantially Equivalent (SESE)
Decision date
1987-01-12
Date received
1986-12-15
Regulation
878.5900
Classification name
Tourniquet, Nonpneumatic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DANIEL W MCELANEY
Address
7 Cross St. P.O. Box 1556 Plainville MA US 02762 02762

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931198UNIQUETIcat Systems1993-09-01
K881398TOURNIQUETBarretta Products, Research and Development, Inc.1988-04-29
K881176STERILE ESMARCH BANDAGESpectrum/Hydro-Med Products, Inc.1988-04-11
K875092DEGANIA SILICONE TOURNIQUETDegania Silicone , Ltd.1988-01-07
K873928UNIVERSAL TOURNIQUETDryden Corp.1987-10-23
K872003KINDERWRAPThe Kinder Co.1987-06-23
K853472FINGER TOURNIQUETTEJoseph B. Marogil1985-10-10
K853537VELCRO TOURNIQUETCp Medical1985-09-12
K852277CATAPRESS TOURNIGUETBoehringer Ingelheim Pharmaceuticals, Inc.1985-06-27
K851482TOURNIQUETPolymer Technology Corp.1985-04-29
K843056ELASTIC BANDAGESterile Medical Systems1984-12-04
K840489DISPOSIQUET A DISPOS. TOURNIQUETMed Lab Products1984-03-12
K830467TOURNIQUET/LATEX TOURNIQUETPrimeline Industries, Inc.1983-03-31
K822553PRESSURE-QUET TOURNIQUETNutec Med, Inc.1982-09-17
K821700LATEX PENROSE DRAIN TUBINGAbco Dealers, Inc.1982-06-16

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