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FDA 510(k)

ORTHOPEDIC CASTING TAPE MAXCAST

K-Number: K832237 · 1983-08-16

ApplicantCutter Laboratories, Inc.
Decision Date1983-08-16
Product CodeITG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC CASTING TAPE MAXCAST is the device name listed in this FDA 510(k) record. The listed applicant is Cutter Laboratories, Inc.. It received FDA 510(k) clearance on 1983-08-16 under 510(k) number K832237. 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 ORTHOPEDIC CASTING TAPE MAXCAST?

ORTHOPEDIC CASTING TAPE MAXCAST is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Cutter Laboratories, Inc.. The 510(k) number is K832237.

When did ORTHOPEDIC CASTING TAPE MAXCAST receive FDA 510(k) clearance?

ORTHOPEDIC CASTING TAPE MAXCAST received FDA 510(k) clearance on 1983-08-16, under 510(k) number K832237.

Who is the listed applicant for ORTHOPEDIC CASTING TAPE MAXCAST?

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

What is the FDA product code for ORTHOPEDIC CASTING TAPE MAXCAST?

The FDA product code for ORTHOPEDIC CASTING TAPE MAXCAST is ITG.

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Other records listing Cutter Laboratories, 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.

K861315HYPERBARIC PENETRATION EXTENSION SETK854106BAYSILEXK842324PERFOURMK834106INTRAVENOUS INFUSION CONTROLLERK823214DOSIMETRIC RELEASE PROGRAM - ADMIN. SETK821326CUTTER BOND POLYCARBOXYLATE CEMENT

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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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