510(k) K060648

REPROCESSED PHACOEMULSIFICATION TIPS by Alliance Medical Corp. — Product Code NKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 19, 2007
Date Received: March 13, 2006
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Needle, Phacoemulsification, Reprocessed
Device Class: Class II
Regulation Number: 886.4670
Review Panel: OP
Submission Type

Needle for phacoemulsification device to remove cataractous lens. Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a "reprocessed" needle. The Phacoemulsification device is NOT reprocessed, just the needle. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Alliance Medical Corp.

K061045 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (August 31, 2006)
K051438 — VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) (April 4, 2006)
K060049 — REPROCESSED COMPRESSION SLEEVES (February 24, 2006)
K060091 — ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES (February 17, 2006)
K053316 — REPROCESSED COMPRESSION SLEEVES (February 13, 2006)
K052918 — REPROCESSED EXTERNAL FIXATION DEVICES (January 27, 2006)
K052603 — REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS (November 16, 2005)
K052414 — REPROCESSED ELECTROPHYSIOLOGY CATHETER (November 16, 2005)
K050518 — REPROCESSED PHACOEMUISIFICATION TIPS (September 23, 2005)
K052064 — ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES (August 25, 2005)

510(k) K060648

Clearance Details

Device Classification

Other clearances by Alliance Medical Corp.

Other clearances for product code NKX