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FDA 510(k)

PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM

K-Number: K944040 · 1995-07-21

ApplicantS & S X-Ray Products, Inc.
Decision Date1995-07-21
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is S & S X-Ray Products, Inc.. It received FDA 510(k) clearance on 1995-07-21 under 510(k) number K944040. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM?

PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-07-21. The listed applicant is S & S X-Ray Products, Inc.. The 510(k) number is K944040.

When did PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM receive FDA 510(k) clearance?

PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM received FDA 510(k) clearance on 1995-07-21, under 510(k) number K944040.

Who is the listed applicant for PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM?

The FDA 510(k) record lists S & S X-Ray Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM?

The FDA product code for PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM is IYE.

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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Other records listing S & S X-Ray Products, 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.

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Related Devices (Code: IYE)

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Official Source

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