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FDA 510(k)

METAL FRAME, PLASTIC FRAME

K-Number: K945895 · 1995-03-02

Decision Date1995-03-02
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

METAL FRAME, PLASTIC FRAME is the device name listed in this FDA 510(k) record. The listed applicant is Sun Vista Intl., Inc.. It received FDA 510(k) clearance on 1995-03-02 under 510(k) number K945895. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METAL FRAME, PLASTIC FRAME?

METAL FRAME, PLASTIC FRAME is a medical device that received FDA 510(k) clearance on 1995-03-02. The listed applicant is Sun Vista Intl., Inc.. The 510(k) number is K945895.

When did METAL FRAME, PLASTIC FRAME receive FDA 510(k) clearance?

METAL FRAME, PLASTIC FRAME received FDA 510(k) clearance on 1995-03-02, under 510(k) number K945895.

Who is the listed applicant for METAL FRAME, PLASTIC FRAME?

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

What is the FDA product code for METAL FRAME, PLASTIC FRAME?

The FDA product code for METAL FRAME, PLASTIC FRAME is HQY.

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.

Related Devices (Code: HQY)

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.

Official Source

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