Duralastic I

FDA 510(k) K955368 · Allied Biomedical Corp.

Substantially Equivalent

510(k) numberK955368

Submission

Device name
Duralastic I
Applicant
Allied Biomedical Corp.
Goose Creek, SC, US
Received
November 22, 1995
Decision date
February 8, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MIB – Elastomer, Silicone Block
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3620
Specialty
Ear, Nose, Throat
Implant
Yes

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More from Implantech Associates, Inc.

510(k)DeviceDecision
K982051Kelocate SheetingMDA · Traditional 08/05/1998SE
K971481Duralastic Anatomical Nasal ImplantsFZE · Traditional 07/18/1997SE
K971479Duralastic Anatomical Malar ImplantsLZK · Traditional 07/18/1997SE
K971478Duralastic Anatomical Chin ImplantsFWP · Traditional 07/18/1997SE
K971480Duralastic I and Duralastic IIMIB · Traditional 05/28/1997SE
K955370Duralastic IIMIB · Traditional 02/08/1996SE
K955433Duralastic Silicone TubingKGZ · Traditional 01/26/1996SE
K954413KelocoteMDA · Traditional 11/29/1995SE

Questions and answers

When was Duralastic I cleared by the FDA?

Duralastic I (K955368) received a 510(k) decision of Substantially Equivalent on February 8, 1996, 78 days after the submission was received.

What is the product code of K955368?

The FDA product code is MIB – Elastomer, Silicone Block, a Class II (moderate risk) device regulated under 21 CFR 874.3620.