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FDA 510(k)

STRAITH NASAL IMPLANT

K-Number: K801074 · 1980-06-17

ApplicantSurgical Technology Laboratories, Inc.
Decision Date1980-06-17
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRAITH NASAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1980-06-17 under 510(k) number K801074. The device is classified under product code FZE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRAITH NASAL IMPLANT?

STRAITH NASAL IMPLANT is a medical device that received FDA 510(k) clearance on 1980-06-17. The listed applicant is Surgical Technology Laboratories, Inc.. The 510(k) number is K801074.

When did STRAITH NASAL IMPLANT receive FDA 510(k) clearance?

STRAITH NASAL IMPLANT received FDA 510(k) clearance on 1980-06-17, under 510(k) number K801074.

Who is the listed applicant for STRAITH NASAL IMPLANT?

The FDA 510(k) record lists Surgical Technology Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRAITH NASAL IMPLANT?

The FDA product code for STRAITH NASAL IMPLANT is FZE.

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Other records listing Surgical Technology Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170582Saf-T-Vac Smoke and Fluid EvacuatorK021889SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)K983756SURGIFORM ANATOMICAL MALARK983755NASAL DORSAL SERIESK983754STANDARD CHINK964443SURGIFORM ANATOMICAL MALAR

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Related Devices (Code: FZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc.K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.K090803HANSON MEDICAL FACIAL IMPLANTSHanson Medical, Inc.K090630NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)Nobel Biocare ABK071018MONARCH NASAL IMPLANTHanson Medical, Inc.K041690MONARCH NASAL IMPLANTHanson Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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