FDA 510(k)

LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.

K-Number: K802381 · 1980-12-17

Decision Date1980-12-17

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. is the device name listed in this FDA 510(k) record. The listed applicant is Fibra Sonics, Inc.. It received FDA 510(k) clearance on 1980-12-17 under 510(k) number K802381. 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 LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.?

LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. is a medical device that received FDA 510(k) clearance on 1980-12-17. The listed applicant is Fibra Sonics, Inc.. The 510(k) number is K802381.

When did LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. receive FDA 510(k) clearance?

LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. received FDA 510(k) clearance on 1980-12-17, under 510(k) number K802381.

Who is the listed applicant for LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.?

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

What is the FDA product code for LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.?

The FDA product code for LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. is HQC.

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Other records listing Fibra Sonics, Inc. as applicant

K993046FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 K984199EXONIX K984143FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM K983199FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL K980930FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA K842024ULTRASONIC LITHOTRIPTOR 300A

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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.