I.V. BAG ADDISEAL

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. Bag Addiseal.

Pre-market Notification Details

• Device ID: K832247
• 510k Number: K832247
• Device Name: I.V. BAG ADDISEAL
• Classification: Container, I.v.
• Applicant: BAXA CORP., SUB. OF COOK GROUP, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: KPE
• CFR Regulation Number: 880.5025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-07-11
• Decision Date: 1983-07-26