CAPHOSOL

Saliva, Artificial

INPHARMA A.S.

The following data is part of a premarket notification filed by Inpharma A.s. with the FDA for Caphosol.

Pre-market Notification Details

• Device ID: K030802
• 510k Number: K030802
• Device Name: CAPHOSOL
• Classification: Saliva, Artificial
• Applicant: INPHARMA A.S. 96 WEST MAIN ST. Northborough, MA 01532
• Contact: Bruce Manning
• Correspondent: Bruce Manning; INPHARMA A.S. 96 WEST MAIN ST. Northborough, MA 01532
• Product Code: LFD
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-03-13
• Decision Date: 2003-11-25
• Summary: summary