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FDA 510(k)

EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)

K-Number: K962938 · 1996-10-25

ApplicantExcelsior Medical Corp.
Decision Date1996-10-25
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) is the device name listed in this FDA 510(k) record. The listed applicant is Excelsior Medical Corp.. It received FDA 510(k) clearance on 1996-10-25 under 510(k) number K962938. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)?

EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) is a medical device that received FDA 510(k) clearance on 1996-10-25. The listed applicant is Excelsior Medical Corp.. The 510(k) number is K962938.

When did EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) receive FDA 510(k) clearance?

EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) received FDA 510(k) clearance on 1996-10-25, under 510(k) number K962938.

Who is the listed applicant for EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)?

The FDA 510(k) record lists Excelsior Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)?

The FDA product code for EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) is FOZ.

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Other records listing Excelsior Medical Corp. 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.

K130975SWABCAP AND SWABFLUSHK101270SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311K083508SWABCAPK082837STERILE FIELD SALINE PRE-FILLED SYRINGE(S)K061497SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/MLK053120STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES

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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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