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510(k) K895039

Device
STERILE SALINE - FOR SUCTION CATHETER LUBRICATION
Applicant
APLICARE, INC.
510(k) number
K895039
Product code
GCX  
Decision
Substantially Equivalent (SESE)
Decision date
1989-10-03
Date received
1989-08-09
Regulation
880.6740
Classification name
Apparatus, Suction, Operating-room, Wall Vacuum Powered
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAUL G BUCCETTI
Address
7 Orchard Park Rd. Madison CT US 06443 06443

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K042454STRYKER CASSETTE PUMPStryker Endoscopy2004-12-09
K992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMCircon Corp.1999-08-03
K972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.1997-07-25
K971022CHASE SUCKERChase Medical, Inc.1997-04-17
K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.1996-12-31
K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health1996-12-20
K963648STRYKER SUCTION REGULATORStryker Endoscopy1996-11-26
K962920RENTON SUCTION DEVICE U.S. PATENT*4,767,404R&S Surgical, LLC1996-10-21
K961880MEDCARE SUCTION CONNECTING TUBINGMedcare Medical Group, Inc.1996-07-19
K960223CPR YANKAUERCustom Pack Reliability1996-03-28
K954869MEDCARE YANKAUER SUCTION DEVICEMedcare Custom Packaging, Inc.1996-01-19
K954726STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)Stryker Endoscopy1995-11-29
K952219SUCTION TIP CLEANER CUPMoore/Gobel1995-11-15
K951119NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEMAmerican Hydro-Surgical Instruments, Inc.1995-06-13
K950464SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLESSscor1995-04-25

Legacy Summary#

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FDA Review#

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