FDA.reportPublic FDA data

510(k) K923876

Device
RISKONTROL SINGLE USE
Applicant
RISKONTROL
510(k) number
K923876
Product code
ECB  
Decision
Substantially Equivalent (SESE)
Decision date
1993-04-05
Date received
1992-08-03
Regulation
872.4565
Classification name
Unit, Syringe, Air And/or Water
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ERICK F CARLGREN
Address
524 E. Coronado Rd. Santa Fe NM US 87501 87501

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ECB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K942519UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPSBull Frog Mfg. Co.1994-08-23
K931772SURETIP SYRINGE TIP COVERWestern M/D, Inc.1994-03-07
K931137DENTAL SYRINGE TIPA-Dec, Inc.1993-11-29
K923285PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLESmith & Nephew, Inc.1992-09-15
K920499SANI-TIPDw Industries, Inc.1992-05-03
K911756POSTERIOR NASAL EPISTAXIS INSTRUMENTSRichard Wolf Medical Instruments Corp.1991-10-24
K890290BRACE (ORAFIX SPECIAL)Norcliff Thayer, Inc.1989-03-29
K863024SERINGA TRIPLICE S.L.Sds Dental, Inc.1986-09-25
K854699TUBING SYRINGAlmore Intl., Inc.1986-01-06
K801686SPACELINE THREE WAY SYRINGEPacific Dental Corp.1980-08-04
K781594DENTAL WARM WATER IRRIGATING SYSTEMRama Corp.1978-12-04

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