510(k) K884413

Device: CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR
Applicant: VALLEYLAB, INC.
510(k) number: K884413
Product code: LBK
Decision: Substantially Equivalent (SESE)
Decision date: 1988-12-02
Date received: 1988-10-20
Regulation: 510(k) Premarket Notification
Classification name: Device, Neurosurgical Fragmentation And Aspiration
Medical specialty: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Review panel: Neurology
Device class: U
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Contact: PEGGY WALLINE
Address: 5920 Longbow Dr. Boulder CO US 80301 80301

FDA Registration Numbers#

1721676
2648988
1722139
3003418325
3012507533
3009116370
1220477
1319639
1722447
3004608878
3006697299
1221053

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LBK #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K972612	DISSECTRON PORTABLE UNIT	Satelec	1997-10-08
K962952	OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)	Olympus Optical, Co.	1996-11-29
K884412	CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.	Valleylab, Inc.	1988-12-02
K883522	AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT	Amerimed US Corp.	1988-09-30
K855138	BOVIE ULTRASONIC SURGICAL SYSTEM	Clinical Technology Corp.	1986-11-10
K853143	COOPER LASER SONICS CUSA MODEL 200	Cooper Lasersonics, Inc.	1985-10-16

Legacy Summary#

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