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FDA 510(k)

HEAD HALTER

K-Number: K830245 · 1983-03-09

ApplicantWarm & Form, Orthopedic Materials
Decision Date1983-03-09
Product CodeILZ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEAD HALTER 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 1983-03-09 under 510(k) number K830245. The device is classified under product code ILZ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEAD HALTER?

HEAD HALTER is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Warm & Form, Orthopedic Materials. The 510(k) number is K830245.

When did HEAD HALTER receive FDA 510(k) clearance?

HEAD HALTER received FDA 510(k) clearance on 1983-03-09, under 510(k) number K830245.

Who is the listed applicant for HEAD HALTER?

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 HEAD HALTER?

The FDA product code for HEAD HALTER is ILZ.

Related Clinical Trials

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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.

K830244TRACTION ACCESSORIESK830243ABDUCTION PILLOWK830246CAST SHOE, CAST BOOTK823661CLAVICLE SUPPORTK823663ABDOMINAL BINDERK823667CERVICAL COLLAR

View all 24 devices →

Related Devices (Code: ILZ)

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.

K921711FLEXION DISTRATION SUPPORTAltoona Medical SupplyK895382VIBRA-TRAC TRACTION TABLEVibra-Trac IndustriesK884340AMX-110, AMX-II AND AMX-IIIDyna-MedK852398VECTOR BAR SUSPENSION/TRACTION UNITPowlan Manufacturing Co.K844490TRACTION ACCESSORIESJerome MedicalK831135SAUNDERS #7080 CERVICAL TRACTION SYSChattanooga Group, 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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