FDA 510(k)

POLYCORE

K-Number: K832461 · 1983-08-16

Decision Date1983-08-16

Product Code

DecisionSubstantially Equivalent

Device Summary

POLYCORE is the device name listed in this FDA 510(k) record. The listed applicant is Polycore Optical Pte , Ltd.. It received FDA 510(k) clearance on 1983-08-16 under 510(k) number K832461. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYCORE?

POLYCORE is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Polycore Optical Pte , Ltd.. The 510(k) number is K832461.

When did POLYCORE receive FDA 510(k) clearance?

POLYCORE received FDA 510(k) clearance on 1983-08-16, under 510(k) number K832461.

Who is the listed applicant for POLYCORE?

The FDA 510(k) record lists Polycore Optical Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Polycore Optical Pte , Ltd. as applicant

K822429SINGLE VISION POWER LENS K822430KRYPTOX-ROUND SEGMENT BIFOCAL K822541VISIOPAL 75 K822431SUNGLASS & SAFETY PLANO LENS K822542POLYCORE K790215LENS, POLYCORE

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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.