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510(k) K853295

Device
EMODREN EXCHANGEABLE PLASTIC BELLOWS
Applicant
PAREXEL INTL. CORP.
510(k) number
K853295
Product code
GCY  
Decision
Substantially Equivalent (SESE)
Decision date
1985-08-20
Date received
1985-08-06
Regulation
878.4680
Classification name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JULIAN P KAYE
Address
55 Wheeler St. Cambridge MA US 02138 02138

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972703REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.1997-10-01
K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.1997-06-03
K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.1996-12-12
K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.1996-03-11
K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.1995-04-25
K936223PRESSURE IRRIGATING SYSTEMLevel 1 Technologies, Inc.1994-05-12
K930615AUTOVAC CLOSED WOUND SUCTION SYSTEMBoehringer Laboratories1994-02-22
K933319BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEMBirtcher Medical Systems, Inc.1993-10-27
K933305IMC 5.0MM IRRIGATION/ASPIRATION PROBEInman Medical Corp.1993-10-05
K933306IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLESInman Medical Corp.1993-10-05
K933170INMAN POOLE TIP SUCTION PROBE W/TUBING KITInman Medical Corp.1993-09-16
K931950POOLE TIP SUCTION PROBEMayaguez Medical Center1993-08-11
K9318565.0 MM IRRIGATION/ASPIRATION PROBEMayaguez Medical Center1993-08-10
K925024ORC TAPPERED IRRIGATING PROBEO.R. Concepts, Inc.1993-05-21
K923908# 9455 AND #9457 POOLE TIP SUCTION PROBEO.R. Concepts, Inc.1993-05-17

Legacy Summary#

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FDA Review#

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