THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751

Tubes, Gastrointestinal (and Accessories)

DALE MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Dale Medical Products, Inc. with the FDA for The Dale Ace Connector (access Controller For Enteral), Model H84104751.

Pre-market Notification Details

• Device ID: K082241
• 510k Number: K082241
• Device Name: THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751
• Classification: Tubes, Gastrointestinal (and Accessories)
• Applicant: DALE MEDICAL PRODUCTS, INC. 49 PLAIN STREET North Attleboro, MA 02760
• Contact: Rosina Robinson
• Correspondent: Rosina Robinson; DALE MEDICAL PRODUCTS, INC. 49 PLAIN STREET North Attleboro, MA 02760
• Product Code: KNT
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-08-07
• Decision Date: 2008-10-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H84104851	K082241	000
H84104751	K082241	000