FDA 510(k)

I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)

K-Number: K904612 · 1990-12-26

Decision Date1990-12-26

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Technical Products. It received FDA 510(k) clearance on 1990-12-26 under 510(k) number K904612. 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 I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)?

I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM) is a medical device that received FDA 510(k) clearance on 1990-12-26. The listed applicant is Medical Technical Products. The 510(k) number is K904612.

When did I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM) receive FDA 510(k) clearance?

I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM) received FDA 510(k) clearance on 1990-12-26, under 510(k) number K904612.

Who is the listed applicant for I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)?

The FDA 510(k) record lists Medical Technical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)?

The FDA product code for I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM) is HQC.

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Other records listing Medical Technical Products as applicant

K940083STANDARD PHACO TIP 15, 30, 45, 60 K940088MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE K940084MODEL 2000 OPHTHALMIC SURGICAL SYSTEM K910335MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA K905251MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A K871473PART #860065 IA PAK & PART #860060 IA PAK

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Related Devices (Code: HQC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.