Robinson Middle Ear Prosthesis

FDA 510(k) K760570 · Xomed, Inc.

Substantially Equivalent

510(k) numberK760570

Submission

Device name
Robinson Middle Ear Prosthesis
Applicant
Xomed, Inc.
Arnold, MO, US
Received
September 1, 1976
Decision date
September 21, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EIB – Syringe, Irrigating (Dental)
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EIB

510(k)DeviceApplicantDecision
K911118DTF-1000LL,DTF-1000EIB · Traditional Cp Medical11/20/1991SE
K874543Model OPO-32 Irrigation SleeveEIB · Traditional Allergan, Inc.01/14/1988SE
K822411System 80 Faceplate-In-The-Ear #F1EIB · Traditional Western Advanced Technology, Inc.07/12/1983SE

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Questions and answers

When was Robinson Middle Ear Prosthesis cleared by the FDA?

Robinson Middle Ear Prosthesis (K760570) received a 510(k) decision of Substantially Equivalent on September 21, 1976, 20 days after the submission was received.

What is the product code of K760570?

The FDA product code is EIB – Syringe, Irrigating (Dental), a Class I (low risk) device regulated under 21 CFR 872.4565.