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510(k) K863024

Device
SERINGA TRIPLICE S.L.
Applicant
SDS DENTAL, INC.
510(k) number
K863024
Product code
ECB  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-25
Date received
1986-08-08
Regulation
872.4565
Classification name
Unit, Syringe, Air And/or Water
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CESAR CORAL
Address
4321 Wisconsin Ave. N.W Suite 200 Washington DC US 20016 20016

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
K923876RISKONTROL SINGLE USERiskontrol1993-04-05
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
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#

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FDA Review#

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