FDA 510(k)

STERILE EMPTY PCA SYRINGE

K-Number: K945797 · 1995-05-19

Decision Date1995-05-19

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERILE EMPTY PCA SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medication Systems, Ltd.. It received FDA 510(k) clearance on 1995-05-19 under 510(k) number K945797. 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 EMPTY PCA SYRINGE?

STERILE EMPTY PCA SYRINGE is a medical device that received FDA 510(k) clearance on 1995-05-19. The listed applicant is Intl. Medication Systems, Ltd.. The 510(k) number is K945797.

When did STERILE EMPTY PCA SYRINGE receive FDA 510(k) clearance?

STERILE EMPTY PCA SYRINGE received FDA 510(k) clearance on 1995-05-19, under 510(k) number K945797.

Who is the listed applicant for STERILE EMPTY PCA SYRINGE?

The FDA 510(k) record lists Intl. Medication Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE EMPTY PCA SYRINGE?

The FDA product code for STERILE EMPTY PCA SYRINGE 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.