FINE-JECT

Needle, Hypodermic, Single Lumen

HENKE SASS WOLF OF AMERICA, INC.

The following data is part of a premarket notification filed by Henke Sass Wolf Of America, Inc. with the FDA for Fine-ject.

Pre-market Notification Details

• Device ID: K983067
• 510k Number: K983067
• Device Name: FINE-JECT
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: HENKE SASS WOLF OF AMERICA, INC. SOROCO INDUSTRIAL PARK ROUTE 131 Southbridge, MA 01550
• Contact: Ellen J Henke
• Correspondent: Ellen J Henke; HENKE SASS WOLF OF AMERICA, INC. SOROCO INDUSTRIAL PARK ROUTE 131 Southbridge, MA 01550
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-09-02
• Decision Date: 1998-10-30
• Summary: summary