COVER UP

Cement, Dental

PARKELL

The following data is part of a premarket notification filed by Parkell with the FDA for Cover Up.

Pre-market Notification Details

• Device ID: K881914
• 510k Number: K881914
• Device Name: COVER UP
• Classification: Cement, Dental
• Applicant: PARKELL 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735
• Contact: Nelson J Gendusa
• Correspondent: Nelson J Gendusa; PARKELL 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735
• Product Code: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-05-09
• Decision Date: 1988-07-15