PROLONG

Needle, Conduction, Anesthetic (w/wo Introducer)

LIFE-TECH, INC.

The following data is part of a premarket notification filed by Life-tech, Inc. with the FDA for Prolong.

Pre-market Notification Details

• Device ID: K081864
• 510k Number: K081864
• Device Name: PROLONG
• Classification: Needle, Conduction, Anesthetic (w/wo Introducer)
• Applicant: LIFE-TECH, INC. 4235 GREENBRIAR DR. Stafford, TX 77477 -3995
• Contact: Jeff Kasoff
• Correspondent: Jeff Kasoff; LIFE-TECH, INC. 4235 GREENBRIAR DR. Stafford, TX 77477 -3995
• Product Code: BSP
• CFR Regulation Number: 868.5150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-07-01
• Decision Date: 2008-09-25