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FDA 510(k)

IRIS RETRACTOR

K-Number: K770222 · 1977-02-17

ApplicantConcept, Inc.
Decision Date1977-02-17
Product CodeHNI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRIS RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1977-02-17 under 510(k) number K770222. The device is classified under product code HNI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRIS RETRACTOR?

IRIS RETRACTOR is a medical device that received FDA 510(k) clearance on 1977-02-17. The listed applicant is Concept, Inc.. The 510(k) number is K770222.

When did IRIS RETRACTOR receive FDA 510(k) clearance?

IRIS RETRACTOR received FDA 510(k) clearance on 1977-02-17, under 510(k) number K770222.

Who is the listed applicant for IRIS RETRACTOR?

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

What is the FDA product code for IRIS RETRACTOR?

The FDA product code for IRIS RETRACTOR is HNI.

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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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