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FDA 510(k)

ALVEOGRAF DURAPATITE(18-40 MESH)

K-Number: K813257 · 1982-01-05

ApplicantSterling Drug, Inc.
Decision Date1982-01-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALVEOGRAF DURAPATITE(18-40 MESH) is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Drug, Inc.. It received FDA 510(k) clearance on 1982-01-05 under 510(k) number K813257. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALVEOGRAF DURAPATITE(18-40 MESH)?

ALVEOGRAF DURAPATITE(18-40 MESH) is a medical device that received FDA 510(k) clearance on 1982-01-05. The listed applicant is Sterling Drug, Inc.. The 510(k) number is K813257.

When did ALVEOGRAF DURAPATITE(18-40 MESH) receive FDA 510(k) clearance?

ALVEOGRAF DURAPATITE(18-40 MESH) received FDA 510(k) clearance on 1982-01-05, under 510(k) number K813257.

Who is the listed applicant for ALVEOGRAF DURAPATITE(18-40 MESH)?

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

What is the FDA product code for ALVEOGRAF DURAPATITE(18-40 MESH)?

The FDA product code for ALVEOGRAF DURAPATITE(18-40 MESH) is DZE.

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Other records listing Sterling Drug, Inc. as applicant

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.

K901369GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE IIK896110BIOBRANE(R) IIK875275WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMERK840260PERIOGRAF DURAPATITE 40-60 MESHK820164EMPTY STERILE CARPUJECTK820023CONAGRAF TM DURAPATITE CONES

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Related Devices (Code: DZE)

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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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