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FDA 510(k)

AORP4000 REUSABLE PAK

K-Number: K931358 · 1994-02-22

ApplicantAmerican Optical Corp.
Decision Date1994-02-22
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AORP4000 REUSABLE PAK is the device name listed in this FDA 510(k) record. The listed applicant is American Optical Corp.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K931358. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AORP4000 REUSABLE PAK?

AORP4000 REUSABLE PAK is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is American Optical Corp.. The 510(k) number is K931358.

When did AORP4000 REUSABLE PAK receive FDA 510(k) clearance?

AORP4000 REUSABLE PAK received FDA 510(k) clearance on 1994-02-22, under 510(k) number K931358.

Who is the listed applicant for AORP4000 REUSABLE PAK?

The FDA 510(k) record lists American Optical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AORP4000 REUSABLE PAK?

The FDA product code for AORP4000 REUSABLE PAK is HQC.

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Other records listing American Optical Corp. 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.

K950881PHACO TIPK950880AOI UNIVERSAL ULTRASONIC HANDPIECEK931354P4000 PHACOEMULSIFIERK931357AOD4000 DISPOSABLE PAKK820790FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3K813430TISSUE PROCESSING CASSETTES & ACCESS

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Related Devices (Code: HQC)

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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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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