I.V. PLASTIC BAG

Container, I.v.

MEDI-PLAST INTL., INC.

The following data is part of a premarket notification filed by Medi-plast Intl., Inc. with the FDA for I.v. Plastic Bag.

Pre-market Notification Details

• Device ID: K811233
• 510k Number: K811233
• Device Name: I.V. PLASTIC BAG
• Classification: Container, I.v.
• Applicant: MEDI-PLAST INTL., 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: 1981-05-04
• Decision Date: 1981-06-17