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FDA 510(k)

URETHANE ORTHOPAEDIC CASTING TAPE

K-Number: K820890 · 1982-06-23

ApplicantHexcel Medical
Decision Date1982-06-23
Product CodeITG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

URETHANE ORTHOPAEDIC CASTING TAPE is the device name listed in this FDA 510(k) record. The listed applicant is Hexcel Medical. It received FDA 510(k) clearance on 1982-06-23 under 510(k) number K820890. 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 URETHANE ORTHOPAEDIC CASTING TAPE?

URETHANE ORTHOPAEDIC CASTING TAPE is a medical device that received FDA 510(k) clearance on 1982-06-23. The listed applicant is Hexcel Medical. The 510(k) number is K820890.

When did URETHANE ORTHOPAEDIC CASTING TAPE receive FDA 510(k) clearance?

URETHANE ORTHOPAEDIC CASTING TAPE received FDA 510(k) clearance on 1982-06-23, under 510(k) number K820890.

Who is the listed applicant for URETHANE ORTHOPAEDIC CASTING TAPE?

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 URETHANE ORTHOPAEDIC CASTING TAPE?

The FDA product code for URETHANE ORTHOPAEDIC CASTING TAPE 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.

K840416HEXCELITEK812687BRIGHAM II TOTAL HIP SYSTEMK812669SEATTLE II TOTAL HIP SYSTEMK812068PROPOSED CONTROLS FOR DOSIMETRIC RELEASEK811164URETHANE ORTHOPAEDIC CASTING TAPEK810957MARCOVE INTRAMEDULLARY ROD

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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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