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FDA 510(k)

ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)

K-Number: K993190 · 2000-02-10

ApplicantSurgical Instrument Systems (Sis), Ltd.
Decision Date2000-02-10
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Systems (Sis), Ltd.. It received FDA 510(k) clearance on 2000-02-10 under 510(k) number K993190. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)?

ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) is a medical device that received FDA 510(k) clearance on 2000-02-10. The listed applicant is Surgical Instrument Systems (Sis), Ltd.. The 510(k) number is K993190.

When did ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) receive FDA 510(k) clearance?

ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) received FDA 510(k) clearance on 2000-02-10, under 510(k) number K993190.

Who is the listed applicant for ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)?

The FDA 510(k) record lists Surgical Instrument Systems (Sis), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)?

The FDA product code for ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) is HNO.

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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.

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