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FDA 510(k)

BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700

K-Number: K991637 · 1999-06-22

ApplicantDavol Inc., Sub. C. R. Bard, Inc.
Decision Date1999-06-22
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. It received FDA 510(k) clearance on 1999-06-22 under 510(k) number K991637. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700?

BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 is a medical device that received FDA 510(k) clearance on 1999-06-22. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. The 510(k) number is K991637.

When did BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 receive FDA 510(k) clearance?

BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 received FDA 510(k) clearance on 1999-06-22, under 510(k) number K991637.

Who is the listed applicant for BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700?

The FDA 510(k) record lists Davol Inc., Sub. C. R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700?

The FDA product code for BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 is FTL.

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Other records listing Davol Inc., Sub. C. R. Bard, Inc. as applicant

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K101851VENTRALIGHT ST MESHK092032BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160K081010BARD 3DMAX MESHK061754BARD COMPOSITE L/P MESHK061314BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCHK051848SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079

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Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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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