The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Shea Torp, Otology Implant.
Device ID | K760433 |
510k Number | K760433 |
Device Name: | SHEA TORP, OTOLOGY IMPLANT |
Classification | Replacement, Ossicular Prosthesis, Total |
Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ETA |
CFR Regulation Number | 874.3495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-16 |
Decision Date | 1976-10-05 |