STERICOVER

System, X-ray, Angiographic

STERIMED, INC.

The following data is part of a premarket notification filed by Sterimed, Inc. with the FDA for Stericover.

Pre-market Notification Details

• Device ID: K853044
• 510k Number: K853044
• Device Name: STERICOVER
• Classification: System, X-ray, Angiographic
• Applicant: STERIMED, INC. P.O. BOX #686 Acworth, GA 30101
• Contact: Bruce R Grady
• Correspondent: Bruce R Grady; STERIMED, INC. P.O. BOX #686 Acworth, GA 30101
• Product Code: IZI
• CFR Regulation Number: 892.1600 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-07-19
• Decision Date: 1985-11-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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