MITTENS

Restraint, Protective

DEROYAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Mittens.

Pre-market Notification Details

• Device ID: K963469
• 510k Number: K963469
• Device Name: MITTENS
• Classification: Restraint, Protective
• Applicant: DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849
• Contact: Camille Matlock
• Correspondent: Camille Matlock; DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849
• Product Code: FMQ
• CFR Regulation Number: 880.6760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-09-03
• Decision Date: 1996-11-14
• Summary: summary