Omega Bivalve Nasal Splints

FDA 510(k) K871073 · Omega Silicone, Inc.

Substantially Equivalent

510(k) numberK871073

Submission

Device name
Omega Bivalve Nasal Splints
Applicant
Omega Silicone, Inc.
Santa Barbara, CA, US
Received
March 18, 1987
Decision date
May 11, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FYI – Appliance, Facial Fracture, External
Device class
Class I (low risk)
Regulation
21 CFR 878.3250
Specialty
General, Plastic Surgery

Other 510(k)s with product code FYI

510(k)DeviceApplicantDecision
K821178Ethicon External Fixation WireFYI · Traditional ETHICON, Inc.06/11/1983SE
K801072Straith Nasal SplintFYI · Traditional Surgical Technology Laboratories, Inc.06/17/1980SE
K792106Conphar O.R. Head Cover-SterileFYI · Traditional Conphar, Inc.11/05/1979SE

More from Conphar, Inc.

510(k)DeviceDecision
K871072Omega Nasal Septal ButtonLFB · Traditional 06/08/1987SE
K871070Omega Silicone Chin ImplantFWP · Traditional 05/11/1987SE
K871071Omega Dorsal Columella ImplantsFZE · Traditional 04/13/1987SE
K871074Omega Extended Malar and Omega Contoured MalarFWP · Traditional 04/10/1987SE

Questions and answers

When was Omega Bivalve Nasal Splints cleared by the FDA?

Omega Bivalve Nasal Splints (K871073) received a 510(k) decision of Substantially Equivalent on May 11, 1987, 54 days after the submission was received.

What is the product code of K871073?

The FDA product code is FYI – Appliance, Facial Fracture, External, a Class I (low risk) device regulated under 21 CFR 878.3250.