ACEM

Cord, Electric, For Endoscope

SANDHILL SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Acem.

Pre-market Notification Details

• Device ID: K111013
• 510k Number: K111013
• Device Name: ACEM
• Classification: Cord, Electric, For Endoscope
• Applicant: SANDHILL SCIENTIFIC, INC. 4655 KIRKWOOD CT Boulder, CO 80301
• Contact: Lewis Ward
• Correspondent: Lewis Ward; SANDHILL SCIENTIFIC, INC. 4655 KIRKWOOD CT Boulder, CO 80301
• Product Code: FFZ
• Subsequent Product Code: JOM
• Subsequent Product Code: MYE
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-04-11
• Decision Date: 2011-12-19
• Summary: summary