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FDA 510(k)

CARERITE BIOPACK GINGIVAL RETRACTION CORD

K-Number: K871736 · 1987-05-27

Decision Date1987-05-27
Product CodeJES
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARERITE BIOPACK GINGIVAL RETRACTION CORD is the device name listed in this FDA 510(k) record. The listed applicant is Cost Rite Health Products, Inc.. It received FDA 510(k) clearance on 1987-05-27 under 510(k) number K871736. The device is classified under product code JES. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARERITE BIOPACK GINGIVAL RETRACTION CORD?

CARERITE BIOPACK GINGIVAL RETRACTION CORD is a medical device that received FDA 510(k) clearance on 1987-05-27. The listed applicant is Cost Rite Health Products, Inc.. The 510(k) number is K871736.

When did CARERITE BIOPACK GINGIVAL RETRACTION CORD receive FDA 510(k) clearance?

CARERITE BIOPACK GINGIVAL RETRACTION CORD received FDA 510(k) clearance on 1987-05-27, under 510(k) number K871736.

Who is the listed applicant for CARERITE BIOPACK GINGIVAL RETRACTION CORD?

The FDA 510(k) record lists Cost Rite Health Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARERITE BIOPACK GINGIVAL RETRACTION CORD?

The FDA product code for CARERITE BIOPACK GINGIVAL RETRACTION CORD is JES.

Related Clinical Trials

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.

Other records listing Cost Rite Health Products, 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.

View all 7 devices →

Related Devices (Code: JES)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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