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FDA 510(k)

STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT

K-Number: K913185 · 1991-12-04

ApplicantInternacional Farmaceutica, S.A. DE C.V.
Decision Date1991-12-04
Product CodeGAQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT 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 1991-12-04 under 510(k) number K913185. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT?

STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Internacional Farmaceutica, S.A. DE C.V.. The 510(k) number is K913185.

When did STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT receive FDA 510(k) clearance?

STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT received FDA 510(k) clearance on 1991-12-04, under 510(k) number K913185.

Who is the listed applicant for STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT?

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 STAINLESS STEEL MONOFIL NONABSORB SURG SUT?

The FDA product code for STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT is GAQ.

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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: GAQ)

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.

K203855CoNextions TR Tendon Repair SystemConextions MedicalK193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.K172146MERISTEELM/s. Meril Endo Surgery Private Limited.K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.K081060FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5Core Essence Orthopaedics, LLCK082828SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICESuturtek Incorporated

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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