I.V. ADDITIVE CAP

Container, I.v.

BAXA CORP., SUB. OF COOK GROUP, INC.

The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for I.v. Additive Cap.

Pre-market Notification Details

• Device ID: K802966
• 510k Number: K802966
• Device Name: I.V. ADDITIVE CAP
• Classification: Container, I.v.
• Applicant: BAXA CORP., SUB. OF COOK GROUP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KPE
• CFR Regulation Number: 880.5025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-11-21
• Decision Date: 1981-01-07