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FDA 510(k)

COATED TUNGSTEN EYESHIELD

K-Number: K945515 · 1995-06-19

ApplicantMedtec, Inc.
Decision Date1995-06-19
Product CodeIWS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COATED TUNGSTEN EYESHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc.. It received FDA 510(k) clearance on 1995-06-19 under 510(k) number K945515. The device is classified under product code IWS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COATED TUNGSTEN EYESHIELD?

COATED TUNGSTEN EYESHIELD is a medical device that received FDA 510(k) clearance on 1995-06-19. The listed applicant is Medtec, Inc.. The 510(k) number is K945515.

When did COATED TUNGSTEN EYESHIELD receive FDA 510(k) clearance?

COATED TUNGSTEN EYESHIELD received FDA 510(k) clearance on 1995-06-19, under 510(k) number K945515.

Who is the listed applicant for COATED TUNGSTEN EYESHIELD?

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 COATED TUNGSTEN EYESHIELD?

The FDA product code for COATED TUNGSTEN EYESHIELD is IWS.

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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: IWS)

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.

K940119ROYAL MARSDEN GOLD GRAIN GUNBest IndustriesK943011TUNGSTEN EYESHIELDMedtec, Inc.K934459MED-GENESIS PATIENT LASER EYE SHIELDMed-Genesis, Inc.K934362NUCLEAR ASSOCIATES GLASSERSVictoreen, Inc.K920540RADIOLOGICAL PROTECTIVE EYE SHIELDBurkhart Roentgen Intl., 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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