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FDA 510(k)

AMCON SLIP IN MYDRIATIC SUNGLASSES

K-Number: K942407 · 1994-06-06

ApplicantAmcon Laboratories, Inc.
Decision Date1994-06-06
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AMCON SLIP IN MYDRIATIC SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Amcon Laboratories, Inc.. It received FDA 510(k) clearance on 1994-06-06 under 510(k) number K942407. The device is classified under product code HOY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMCON SLIP IN MYDRIATIC SUNGLASSES?

AMCON SLIP IN MYDRIATIC SUNGLASSES is a medical device that received FDA 510(k) clearance on 1994-06-06. The listed applicant is Amcon Laboratories, Inc.. The 510(k) number is K942407.

When did AMCON SLIP IN MYDRIATIC SUNGLASSES receive FDA 510(k) clearance?

AMCON SLIP IN MYDRIATIC SUNGLASSES received FDA 510(k) clearance on 1994-06-06, under 510(k) number K942407.

Who is the listed applicant for AMCON SLIP IN MYDRIATIC SUNGLASSES?

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

What is the FDA product code for AMCON SLIP IN MYDRIATIC SUNGLASSES?

The FDA product code for AMCON SLIP IN MYDRIATIC SUNGLASSES is HOY.

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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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