The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Trapeze Platinum Ribbon Loop, Otology.
Device ID | K760434 |
510k Number | K760434 |
Device Name: | TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY |
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 | 1976-10-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00821925025264 | K760434 | 000 |
00821925016484 | K760434 | 000 |
00821925016149 | K760434 | 000 |
00821925016132 | K760434 | 000 |
00821925035478 | K760434 | 000 |