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FDA 510(k)

STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE

K-Number: K911189 · 1991-04-25

ApplicantInternacional Farmaceutica, S.A. DE C.V.
Decision Date1991-04-25
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Internacional Farmaceutica, S.A. DE C.V.. It received FDA 510(k) clearance on 1991-04-25 under 510(k) number K911189. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE?

STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE is a medical device that received FDA 510(k) clearance on 1991-04-25. The listed applicant is Internacional Farmaceutica, S.A. DE C.V.. The 510(k) number is K911189.

When did STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE receive FDA 510(k) clearance?

STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE received FDA 510(k) clearance on 1991-04-25, under 510(k) number K911189.

Who is the listed applicant for STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE?

The FDA 510(k) record lists Internacional Farmaceutica, S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE?

The FDA product code for STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE is GAW.

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Other records listing Internacional Farmaceutica, S.A. DE C.V. 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: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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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