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FDA 510(k)

NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)

K-Number: K883213 · 1988-09-15

ApplicantNidek, Inc.
Decision Date1988-09-15
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS) is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1988-09-15 under 510(k) number K883213. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)?

NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS) is a medical device that received FDA 510(k) clearance on 1988-09-15. The listed applicant is Nidek, Inc.. The 510(k) number is K883213.

When did NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS) receive FDA 510(k) clearance?

NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS) received FDA 510(k) clearance on 1988-09-15, under 510(k) number K883213.

Who is the listed applicant for NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)?

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

What is the FDA product code for NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)?

The FDA product code for NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS) is HQF.

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Other records listing Nidek, Inc. as applicant

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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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