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FDA 510(k)

PRE-PADDED PLASTER/PARIS BAND/SPLINTS

K-Number: K800752 · 1980-04-21

ApplicantOrtho-Care, Inc.
Decision Date1980-04-21
Product CodeITG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PRE-PADDED PLASTER/PARIS BAND/SPLINTS is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Care, Inc.. It received FDA 510(k) clearance on 1980-04-21 under 510(k) number K800752. 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 PRE-PADDED PLASTER/PARIS BAND/SPLINTS?

PRE-PADDED PLASTER/PARIS BAND/SPLINTS is a medical device that received FDA 510(k) clearance on 1980-04-21. The listed applicant is Ortho-Care, Inc.. The 510(k) number is K800752.

When did PRE-PADDED PLASTER/PARIS BAND/SPLINTS receive FDA 510(k) clearance?

PRE-PADDED PLASTER/PARIS BAND/SPLINTS received FDA 510(k) clearance on 1980-04-21, under 510(k) number K800752.

Who is the listed applicant for PRE-PADDED PLASTER/PARIS BAND/SPLINTS?

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

What is the FDA product code for PRE-PADDED PLASTER/PARIS BAND/SPLINTS?

The FDA product code for PRE-PADDED PLASTER/PARIS BAND/SPLINTS is ITG.

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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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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