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FDA 510(k)

RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM

K-Number: K853358 · 1985-10-04

ApplicantDentsply Intl.
Decision Date1985-10-04
Product CodeHMF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853358. The device is classified under product code HMF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM?

RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Dentsply Intl.. The 510(k) number is K853358.

When did RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM receive FDA 510(k) clearance?

RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853358.

Who is the listed applicant for RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM?

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

What is the FDA product code for RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM?

The FDA product code for RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM is HMF.

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Related Devices (Code: HMF)

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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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