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FDA 510(k)

THERMOPLASTIC SHIELD

K-Number: K954456 · 1995-12-21

ApplicantMedtec, Inc.
Decision Date1995-12-21
Product CodeKPY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERMOPLASTIC SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc.. It received FDA 510(k) clearance on 1995-12-21 under 510(k) number K954456. The device is classified under product code KPY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOPLASTIC SHIELD?

THERMOPLASTIC SHIELD is a medical device that received FDA 510(k) clearance on 1995-12-21. The listed applicant is Medtec, Inc.. The 510(k) number is K954456.

When did THERMOPLASTIC SHIELD receive FDA 510(k) clearance?

THERMOPLASTIC SHIELD received FDA 510(k) clearance on 1995-12-21, under 510(k) number K954456.

Who is the listed applicant for THERMOPLASTIC SHIELD?

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

What is the FDA product code for THERMOPLASTIC SHIELD?

The FDA product code for THERMOPLASTIC SHIELD is KPY.

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Other records listing Medtec, 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.

K111340HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEMK093738MRI PATIENT POSITIONING DEVICESK974703CARBON FIBER BREAST BOARDK974700MATRIX MT-MX3K973842CARBON FIBER CONFORMAL COUCH TOPK962622INTRA-ORAL THERMOPLASTIC SHIELD

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Related Devices (Code: KPY)

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.

K110900DISPOSABLE THYROID COLLARBloxr CorporationK962622INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.K954146UTK-DTE AUTILARY SHIELDMallinckrodt MedicalK953610AUKULYTEAukland Medical Plastics, Inc.K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)Kenex , Ltd.K951003KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)Kenex , Ltd.

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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