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FDA 510(k)

STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291

K-Number: K981905 · 1998-08-18

ApplicantAcu-Pak
Decision Date1998-08-18
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 is the device name listed in this FDA 510(k) record. The listed applicant is Acu-Pak. It received FDA 510(k) clearance on 1998-08-18 under 510(k) number K981905. 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 STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291?

STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Acu-Pak. The 510(k) number is K981905.

When did STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 receive FDA 510(k) clearance?

STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 received FDA 510(k) clearance on 1998-08-18, under 510(k) number K981905.

Who is the listed applicant for STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291?

The FDA 510(k) record lists Acu-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291?

The FDA product code for STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 is FOZ.

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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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