Straith Nasal Splint

FDA 510(k) K801072 · Surgical Technology Laboratories, Inc.

Substantially Equivalent

510(k) numberK801072

Submission

Device name
Straith Nasal Splint
Applicant
Surgical Technology Laboratories, Inc.
Mchenry, IL, US
Received
May 6, 1980
Decision date
June 17, 1980
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
K871073Omega Bivalve Nasal SplintsFYI · Traditional Omega Silicone, Inc.05/11/1987SE
K821178Ethicon External Fixation WireFYI · Traditional ETHICON, Inc.06/11/1983SE
K792106Conphar O.R. Head Cover-SterileFYI · Traditional Conphar, Inc.11/05/1979SE

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K983754Standard ChinFWP · Special 11/20/1998SE
K964443Surgiform Anatomical MalarLZK · Traditional 12/20/1996SE
K840835Straith Drain InserterFZX · Traditional 04/23/1984SE
K831078Straith Oral AirwayCAE · Traditional 06/24/1983SE
K801074Straith Nasal ImplantFZE · Traditional 06/17/1980SE
K801075Straith Chisel ForcepsGEN · Traditional 05/20/1980SE

Questions and answers

When was Straith Nasal Splint cleared by the FDA?

Straith Nasal Splint (K801072) received a 510(k) decision of Substantially Equivalent on June 17, 1980, 42 days after the submission was received.

What is the product code of K801072?

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