DENTAL STERLIZATION TRAY/CASSETTE

Wrap, Sterilization

BRASSELER USA I, L.P.

The following data is part of a premarket notification filed by Brasseler Usa I, L.p. with the FDA for Dental Sterlization Tray/cassette.

Pre-market Notification Details

• Device ID: K983223
• 510k Number: K983223
• Device Name: DENTAL STERLIZATION TRAY/CASSETTE
• Classification: Wrap, Sterilization
• Applicant: BRASSELER USA I, L.P. 1679 KELLOGG SPRINGS DR. Atlanta, GA 30338
• Contact: Courtney S Paradice
• Correspondent: Courtney S Paradice; BRASSELER USA I, L.P. 1679 KELLOGG SPRINGS DR. Atlanta, GA 30338
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-09-14
• Decision Date: 1999-01-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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