THE DART

Insufflator, Laparoscopic

DEXIDE, INC.

The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for The Dart.

Pre-market Notification Details

• Device ID: K905549
• 510k Number: K905549
• Device Name: THE DART
• Classification: Insufflator, Laparoscopic
• Applicant: DEXIDE, INC. P.O. BOX 185789 Ft. Worth, TX 76181
• Contact: Keith Jung
• Correspondent: Keith Jung; DEXIDE, INC. P.O. BOX 185789 Ft. Worth, TX 76181
• Product Code: HIF
• CFR Regulation Number: 884.1730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-12-11
• Decision Date: 1991-02-19