MANIFOLD WITH EXTENSION SET

Stopcock, I.v. Set

INTERPORE CROSS INTL.

The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Manifold With Extension Set.

Pre-market Notification Details

• Device ID: K982368
• 510k Number: K982368
• Device Name: MANIFOLD WITH EXTENSION SET
• Classification: Stopcock, I.v. Set
• Applicant: INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402
• Contact: Lynn M Rodarti
• Correspondent: Lynn M Rodarti; INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402
• Product Code: FMG
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-07-07
• Decision Date: 1998-07-31
• Summary: summary