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K Number
K983755
Device Name
NASAL DORSAL SERIES
Manufacturer
SURGICAL TECHNOLOGY LABORATORIES, INC.
Date Cleared
1998-11-20

(29 days)

Product Code
FZE
Regulation Number
878.3680
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Surgical Technology Laboratories, Inc. Nasal Dorsal Series implants are intended to be used to augment or reconstruct the nose in rhinoplasty.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Surgical Technology Laboratories, Inc. for their "Nasal Dorsal Series" device. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or details about the clinical studies requested in your prompt.

Therefore, I cannot provide the requested table and study information based on the given document.

§ 878.3680 Nose prosthesis.

(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.