BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING

Tubes, Gastrointestinal (and Accessories)

BIOSEARCH MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Biosearch Dobbhoff(r) Gastrotrac Jejunal Feeding.

Pre-market Notification Details

• Device ID: K900590
• 510k Number: K900590
• Device Name: BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING
• Classification: Tubes, Gastrointestinal (and Accessories)
• Applicant: BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876
• Contact: Peter Waeger
• Correspondent: Peter Waeger; BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876
• Product Code: KNT
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-02-07
• Decision Date: 1990-08-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521007468	K900590	000