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FDA 510(k)

HANKS' BALANCED SALTS (HBSS) NO. H1387

K-Number: K870484 · 1987-03-30

Decision Date1987-03-30
Product CodeKIP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HANKS' BALANCED SALTS (HBSS) NO. H1387 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1987-03-30 under 510(k) number K870484. The device is classified under product code KIP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANKS' BALANCED SALTS (HBSS) NO. H1387?

HANKS' BALANCED SALTS (HBSS) NO. H1387 is a medical device that received FDA 510(k) clearance on 1987-03-30. The listed applicant is Sigma Chemical Co.. The 510(k) number is K870484.

When did HANKS' BALANCED SALTS (HBSS) NO. H1387 receive FDA 510(k) clearance?

HANKS' BALANCED SALTS (HBSS) NO. H1387 received FDA 510(k) clearance on 1987-03-30, under 510(k) number K870484.

Who is the listed applicant for HANKS' BALANCED SALTS (HBSS) NO. H1387?

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

What is the FDA product code for HANKS' BALANCED SALTS (HBSS) NO. H1387?

The FDA product code for HANKS' BALANCED SALTS (HBSS) NO. H1387 is KIP.

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 Sigma Chemical Co. 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.

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Related Devices (Code: KIP)

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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