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FDA 510(k)

GELIPERM GRANULES

K-Number: K823225 · 1983-08-12

ApplicantGeistlich-Pharma
Decision Date1983-08-12
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

GELIPERM GRANULES is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich-Pharma. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K823225. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELIPERM GRANULES?

GELIPERM GRANULES is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Geistlich-Pharma. The 510(k) number is K823225.

When did GELIPERM GRANULES receive FDA 510(k) clearance?

GELIPERM GRANULES received FDA 510(k) clearance on 1983-08-12, under 510(k) number K823225.

Who is the listed applicant for GELIPERM GRANULES?

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

What is the FDA product code for GELIPERM GRANULES?

The FDA product code for GELIPERM GRANULES is FRO. This falls under the Anesthesiology category.

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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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