ACTA

Activator, Ultraviolet, For Polymerization

SATELEC

The following data is part of a premarket notification filed by Satelec with the FDA for Acta.

Pre-market Notification Details

• Device ID: K961735
• 510k Number: K961735
• Device Name: ACTA
• Classification: Activator, Ultraviolet, For Polymerization
• Applicant: SATELEC 70 WALNUT ST. Wellesley, MA 02481
• Contact: Jackie Masse
• Correspondent: Jackie Masse; SATELEC 70 WALNUT ST. Wellesley, MA 02481
• Product Code: EBZ
• CFR Regulation Number: 872.6070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-05-03
• Decision Date: 1996-07-31