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FDA 510(k)

CAST SHOE, CAST BOOT

K-Number: K830246 · 1983-02-18

ApplicantWarm & Form, Orthopedic Materials
Decision Date1983-02-18
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CAST SHOE, CAST BOOT is the device name listed in this FDA 510(k) record. The listed applicant is Warm & Form, Orthopedic Materials. It received FDA 510(k) clearance on 1983-02-18 under 510(k) number K830246. The device is classified under product code JQB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAST SHOE, CAST BOOT?

CAST SHOE, CAST BOOT is a medical device that received FDA 510(k) clearance on 1983-02-18. The listed applicant is Warm & Form, Orthopedic Materials. The 510(k) number is K830246.

When did CAST SHOE, CAST BOOT receive FDA 510(k) clearance?

CAST SHOE, CAST BOOT received FDA 510(k) clearance on 1983-02-18, under 510(k) number K830246.

Who is the listed applicant for CAST SHOE, CAST BOOT?

The FDA 510(k) record lists Warm & Form, Orthopedic Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAST SHOE, CAST BOOT?

The FDA product code for CAST SHOE, CAST BOOT is JQB.

Other records listing Warm & Form, Orthopedic Materials 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.

K830245HEAD HALTERK830244TRACTION ACCESSORIESK830243ABDUCTION PILLOWK823661CLAVICLE SUPPORTK823663ABDOMINAL BINDERK823667CERVICAL COLLAR

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Related Devices (Code: JQB)

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.

K974000Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30Diagnostic Chemicals , Ltd.K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETPointe Scientific, Inc.,K971466SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)Carolina Liquid Chemistries Corp.K964457ROCHE COBAS IBTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.K964916GAMMA-GLUTAMYL TRANSPEPTIDASEDerma Media Lab., Inc.K955770GAMMA GLUTAMYL TRANSFERASE TEST SYSTEMAbaxis, 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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