510(k) K111013

Device: ACEM
Applicant: SANDHILL SCIENTIFIC, INC.
510(k) number: K111013
Product code: FFZ
Decision: Substantially Equivalent (SESE)
Decision date: 2011-12-19
Date received: 2011-04-11
Regulation: 876.1500
Classification name: Cord, Electric, For Endoscope
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: LEWIS WARD
Address: 4655 Kirkwood Ct. Boulder CO US 80301 80301

Source Documents#

Other 510(k) Records For Product Code FFZ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K822254	ELECTRIC CORD FOR ENDOSCOPE	Kelleher Corp.	1982-08-20
K782046	C-CORD	Concept, Inc.	1979-01-10

Legacy Summary#

summary

FDA Review#

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