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FDA 510(k)

SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION

K-Number: K993969 · 1999-12-30

ApplicantWinchester Laboratories, LLC
Decision Date1999-12-30
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Winchester Laboratories, LLC. It received FDA 510(k) clearance on 1999-12-30 under 510(k) number K993969. 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 SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION?

SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION is a medical device that received FDA 510(k) clearance on 1999-12-30. The listed applicant is Winchester Laboratories, LLC. The 510(k) number is K993969.

When did SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION receive FDA 510(k) clearance?

SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION received FDA 510(k) clearance on 1999-12-30, under 510(k) number K993969.

Who is the listed applicant for SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION?

The FDA 510(k) record lists Winchester Laboratories, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION?

The FDA product code for SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION is FRO. This falls under the Anesthesiology category.

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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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