FDA 510(k)

STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)

K-Number: K972728 · 1998-07-15

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1998-07-15

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS) is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1998-07-15 under 510(k) number K972728. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)?

STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS) is a medical device that received FDA 510(k) clearance on 1998-07-15. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K972728.

When did STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS) receive FDA 510(k) clearance?

STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS) received FDA 510(k) clearance on 1998-07-15, under 510(k) number K972728.

Who is the listed applicant for STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)?

The FDA product code for STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS) is FMF.

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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.