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FDA 510(k)

STRUNG TELFA NON-ADHERENT SPONGE

K-Number: K904514 · 1991-03-27

ApplicantAmerican Silk Sutures, Inc.
Decision Date1991-03-27
Product CodeHBA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STRUNG TELFA NON-ADHERENT SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is American Silk Sutures, Inc.. It received FDA 510(k) clearance on 1991-03-27 under 510(k) number K904514. The device is classified under product code HBA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRUNG TELFA NON-ADHERENT SPONGE?

STRUNG TELFA NON-ADHERENT SPONGE is a medical device that received FDA 510(k) clearance on 1991-03-27. The listed applicant is American Silk Sutures, Inc.. The 510(k) number is K904514.

When did STRUNG TELFA NON-ADHERENT SPONGE receive FDA 510(k) clearance?

STRUNG TELFA NON-ADHERENT SPONGE received FDA 510(k) clearance on 1991-03-27, under 510(k) number K904514.

Who is the listed applicant for STRUNG TELFA NON-ADHERENT SPONGE?

The FDA 510(k) record lists American Silk Sutures, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRUNG TELFA NON-ADHERENT SPONGE?

The FDA product code for STRUNG TELFA NON-ADHERENT SPONGE is HBA.

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Other records listing American Silk Sutures, 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.

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Related Devices (Code: HBA)

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.

K193346Codman Surgical Patties & StripsIntegra LifeSciences CorporationK112598AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)American Surgical Company, LLCK121822DELICOTAmerican Surgical Company, LLCK073576NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGESHarod Enterprises, Inc.K062406AESCULAP NEURO PATTIESAesculap, Inc.K031008AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)Aesculap

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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