PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT

Prosthesis, Partial Ossicular Replacement

RICHARD'S MEDICAL EQUIP., INC.

The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Piston, Platinum Teflon, Otology Implant.

Pre-market Notification Details

• Device ID: K760435
• 510k Number: K760435
• Device Name: PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT
• Classification: Prosthesis, Partial Ossicular Replacement
• Applicant: RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: ETB
• CFR Regulation Number: 874.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1976-08-16
• Decision Date: 1976-09-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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