510(k) K093915

Device: DEKA TAC DEVICE
Applicant: DEKA RESEARCH & DEVELOPMENT CORP.
510(k) number: K093915
Product code: FIG
Decision: Substantially Equivalent (SESE)
Decision date: 2011-08-23
Date received: 2009-12-22
Regulation: 876.5820
Classification name: Clamp, Tubing, Blood, Automatic
Medical specialty: Gastroenterology/Urology
Review panel: Gastroenterology/Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: ROBERT SWAIN
Address: 340 Commercial St. Manchester NH US 03101 03101

FDA Registration Numbers#

1220973

Source Documents#

Other 510(k) Records For Product Code FIG #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K921993	ELS AUTOMATIC TUBING CLAMP SYSTEM	Rocky Mountain Research, Inc.	1994-01-05
K914459	AUTOMATIC TUBING CLAMP	Rocky Mountain Research, Inc.	1992-06-24
K770535	C-DAK 3500	Cordis Corp.	1977-04-15

Legacy Summary#

summary

FDA Review#

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