FDA.report

510(k) K924577

Device
MEDIVAC
Applicant
MEDISONIC U.S.A., INC.
510(k) number
K924577
Product code
GCX  
Decision
Substantially Equivalent (SESE)
Decision date
1993-03-23
Date received
1992-09-10
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
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
DON TRAINER
Address
9600 Main St. Clarence NY US 14031 14031

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Other 510(k) Records For Product Code GCX  

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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