CERAVITAL CERAMIC OSSICULAR REPL. PROS.

Replacement, Ossicular Prosthesis, Total

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Ceravital Ceramic Ossicular Repl. Pros..

Pre-market Notification Details

• Device ID: K810707
• 510k Number: K810707
• Device Name: CERAVITAL CERAMIC OSSICULAR REPL. PROS.
• Classification: Replacement, Ossicular Prosthesis, Total
• Applicant: XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010
• Product Code: ETA
• CFR Regulation Number: 874.3495 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-03-16
• Decision Date: 1981-06-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000033330	K810707	000
00763000034771	K810707	000
00763000034788	K810707	000
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00763000034764	K810707	000
00763000034757	K810707	000
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00763000034641	K810707	000
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