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FDA 510(k)

GELIPERM ABSORBIND GRANULATED GEL

K-Number: K850819 · 1985-05-07

ApplicantGeistlich-Pharma
Decision Date1985-05-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

GELIPERM ABSORBIND GRANULATED GEL is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich-Pharma. It received FDA 510(k) clearance on 1985-05-07 under 510(k) number K850819. 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 ABSORBIND GRANULATED GEL?

GELIPERM ABSORBIND GRANULATED GEL is a medical device that received FDA 510(k) clearance on 1985-05-07. The listed applicant is Geistlich-Pharma. The 510(k) number is K850819.

When did GELIPERM ABSORBIND GRANULATED GEL receive FDA 510(k) clearance?

GELIPERM ABSORBIND GRANULATED GEL received FDA 510(k) clearance on 1985-05-07, under 510(k) number K850819.

Who is the listed applicant for GELIPERM ABSORBIND GRANULATED GEL?

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 ABSORBIND GRANULATED GEL?

The FDA product code for GELIPERM ABSORBIND GRANULATED GEL is FRO. This falls under the Anesthesiology category.

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Other records listing Geistlich-Pharma as applicant

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Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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