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FDA 510(k)

HEXCELITE SHEET SPLINTS

K-Number: K760841 · 1976-11-01

ApplicantHexcel Medical
Decision Date1976-11-01
Product CodeITG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEXCELITE SHEET SPLINTS is the device name listed in this FDA 510(k) record. The listed applicant is Hexcel Medical. It received FDA 510(k) clearance on 1976-11-01 under 510(k) number K760841. The device is classified under product code ITG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEXCELITE SHEET SPLINTS?

HEXCELITE SHEET SPLINTS is a medical device that received FDA 510(k) clearance on 1976-11-01. The listed applicant is Hexcel Medical. The 510(k) number is K760841.

When did HEXCELITE SHEET SPLINTS receive FDA 510(k) clearance?

HEXCELITE SHEET SPLINTS received FDA 510(k) clearance on 1976-11-01, under 510(k) number K760841.

Who is the listed applicant for HEXCELITE SHEET SPLINTS?

The FDA 510(k) record lists Hexcel Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEXCELITE SHEET SPLINTS?

The FDA product code for HEXCELITE SHEET SPLINTS is ITG.

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Other records listing Hexcel Medical 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.

K840416HEXCELITEK820890URETHANE ORTHOPAEDIC CASTING TAPEK812687BRIGHAM II TOTAL HIP SYSTEMK812669SEATTLE II TOTAL HIP SYSTEMK812068PROPOSED CONTROLS FOR DOSIMETRIC RELEASEK811164URETHANE ORTHOPAEDIC CASTING TAPE

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Related Devices (Code: ITG)

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.

K873111CONFORMA(TM) PLASTER BANDAGESThe Kendal Co.K862115DEKNA BAND KITDeknatel, Inc.K842573T.P.G. CAST TAPEThe Poly Group, Inc.K840416HEXCELITEHexcel MedicalK833732NON WETTING UNDERCAST PADDINGAmerican Medical Disposable, Inc.K832992SOFFBAN ORTHOPEDIC PADDINGSmith & Nephew, 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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