MINI PAK

Hearing Aid, Air Conduction

STARKEY LABORATORIES, INC.

The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Mini Pak.

Pre-market Notification Details

• Device ID: K941636
• 510k Number: K941636
• Device Name: MINI PAK
• Classification: Hearing Aid, Air Conduction
• Applicant: STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie, MN 55344
• Contact: Rick Stromberg
• Correspondent: Rick Stromberg; STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie, MN 55344
• Product Code: ESD
• CFR Regulation Number: 874.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-04-04
• Decision Date: 1994-05-04