I.V. SET (20 DROPS/ML)

Set, Administration, Intravascular

PURITAS HEALTH CARE, INC.

The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for I.v. Set (20 Drops/ml).

Pre-market Notification Details

• Device ID: K940072
• 510k Number: K940072
• Device Name: I.V. SET (20 DROPS/ML)
• Classification: Set, Administration, Intravascular
• Applicant: PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776
• Contact: Thomas P Dimaio
• Correspondent: Thomas P Dimaio; PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-01-06
• Decision Date: 1994-03-23