FDA 510(k)

ROLLENS POST-MYDRIATIC SUNGLASS

K-Number: K932646 · 1993-09-20

ApplicantRollens Professional Products, Inc.

Decision Date1993-09-20

Product CodeHQY

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

ROLLENS POST-MYDRIATIC SUNGLASS is the device name listed in this FDA 510(k) record. The listed applicant is Rollens Professional Products, Inc.. It received FDA 510(k) clearance on 1993-09-20 under 510(k) number K932646. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROLLENS POST-MYDRIATIC SUNGLASS?

ROLLENS POST-MYDRIATIC SUNGLASS is a medical device that received FDA 510(k) clearance on 1993-09-20. The listed applicant is Rollens Professional Products, Inc.. The 510(k) number is K932646.

When did ROLLENS POST-MYDRIATIC SUNGLASS receive FDA 510(k) clearance?

ROLLENS POST-MYDRIATIC SUNGLASS received FDA 510(k) clearance on 1993-09-20, under 510(k) number K932646.

Who is the listed applicant for ROLLENS POST-MYDRIATIC SUNGLASS?

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

What is the FDA product code for ROLLENS POST-MYDRIATIC SUNGLASS?

The FDA product code for ROLLENS POST-MYDRIATIC SUNGLASS is HQY.

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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.