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FDA 510(k)

SOFTFORM FACIAL IMPLANT

K-Number: K973462 · 1997-11-24

ApplicantTissue Technologies, Inc.
Decision Date1997-11-24
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOFTFORM FACIAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Technologies, Inc.. It received FDA 510(k) clearance on 1997-11-24 under 510(k) number K973462. 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 SOFTFORM FACIAL IMPLANT?

SOFTFORM FACIAL IMPLANT is a medical device that received FDA 510(k) clearance on 1997-11-24. The listed applicant is Tissue Technologies, Inc.. The 510(k) number is K973462.

When did SOFTFORM FACIAL IMPLANT receive FDA 510(k) clearance?

SOFTFORM FACIAL IMPLANT received FDA 510(k) clearance on 1997-11-24, under 510(k) number K973462.

Who is the listed applicant for SOFTFORM FACIAL IMPLANT?

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

What is the FDA product code for SOFTFORM FACIAL IMPLANT?

The FDA product code for SOFTFORM FACIAL IMPLANT is FTL.

Related Clinical Trials

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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Other records listing Tissue Technologies, 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.

K002071SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLESK000849SOFTFORM FACIAL IMPLANTK982475SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOLK970804TRU-PULSE CO2 SURGICAL LASERK963683TRU-PULSE LASER (MODIFIED)K962496SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)

View all 9 devices →

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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