OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT

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 Ossicular Prostheses 4 Partial, 4 Total, 2 Convert.

Pre-market Notification Details

• Device ID: K885201
• 510k Number: K885201
• Device Name: OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT
• Classification: Replacement, Ossicular Prosthesis, Total
• Applicant: MICROBIO-MEDICS, INC. POST OFFICE BOX 2487 Columbus, MS 39704
• Contact: Keith Mcgee
• Correspondent: Keith Mcgee; 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: 1988-12-16
• Decision Date: 1989-04-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000913489	K885201	000
00763000034573	K885201	000
00763000034580	K885201	000
00763000034597	K885201	000
00763000038427	K885201	000
00763000038434	K885201	000
20681490017521	K885201	000
20681490017873	K885201	000
20681490017880	K885201	000
00681490017558	K885201	000
00681490017565	K885201	000
00763000034566	K885201	000
00763000034375	K885201	000
00763000034306	K885201	000
00763000913595	K885201	000
00763000913762	K885201	000
00763000033286	K885201	000
00763000034313	K885201	000
00763000034214	K885201	000
00763000034221	K885201	000
00763000034252	K885201	000
00763000034269	K885201	000
00763000034276	K885201	000
00763000034290	K885201	000
00681490017572	K885201	000
00681490017664	K885201	000
00681490023788	K885201	000
00681490024754	K885201	000
00681490024778	K885201	000
00681490024785	K885201	000
00681490024792	K885201	000
00681490024808	K885201	000
00681490024815	K885201	000
00681490024822	K885201	000
00681490024839	K885201	000
00681490024846	K885201	000
00681490023320	K885201	000
00681490023313	K885201	000
00681490017916	K885201	000
00681490017671	K885201	000
00681490017688	K885201	000
00681490017718	K885201	000
00681490017800	K885201	000
00681490017817	K885201	000
00681490017824	K885201	000
00681490017831	K885201	000
00681490017848	K885201	000
00681490017893	K885201	000
00681490017909	K885201	000
00681490024853	K885201	000