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FDA 510(k)

SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER

K-Number: K901079 · 1990-05-18

ApplicantL H M Ent., Inc.
Decision Date1990-05-18
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER is the device name listed in this FDA 510(k) record. The listed applicant is L H M Ent., Inc.. It received FDA 510(k) clearance on 1990-05-18 under 510(k) number K901079. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER?

SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER is a medical device that received FDA 510(k) clearance on 1990-05-18. The listed applicant is L H M Ent., Inc.. The 510(k) number is K901079.

When did SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER receive FDA 510(k) clearance?

SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER received FDA 510(k) clearance on 1990-05-18, under 510(k) number K901079.

Who is the listed applicant for SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER?

The FDA 510(k) record lists L H M Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER?

The FDA product code for SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER is BTO.

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.

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Other records listing L H M Ent., 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.

K901078SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINEK894610CUSTOM TRAYS, KITSK900439SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CCK894611CATHETER CARE KITSK883506IRRIGATION KIT

Related Devices (Code: BTO)

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

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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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