SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES

Replacement, Ossicular Prosthesis, Total

MICROBIO-MEDICS, INC.

The following data is part of a premarket notification filed by Microbio-medics, Inc. with the FDA for Soft Hydroxylapatite Ossicular Malleable Prosthes.

Pre-market Notification Details

• Device ID: K904239
• 510k Number: K904239
• Device Name: SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES
• Classification: Replacement, Ossicular Prosthesis, Total
• Applicant: MICROBIO-MEDICS, INC. POST OFFICE BOX 2487 Columbus, MS 39704
• Contact: Gregory Smallwood
• Correspondent: Gregory Smallwood; MICROBIO-MEDICS, INC. POST OFFICE BOX 2487 Columbus, MS 39704
• Product Code: ETA
• CFR Regulation Number: 874.3495 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-09-13
• Decision Date: 1991-06-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000033293	K904239	000
00763000034504	K904239	000
00763000034511	K904239	000
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