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FDA 510(k)

SKIFA, PLASTIC DISPOSABLE SYRINGE

K-Number: K883227 · 1988-09-29

ApplicantP.T. Setio Harto , Ltd.
Decision Date1988-09-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SKIFA, PLASTIC DISPOSABLE SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Setio Harto , Ltd.. It received FDA 510(k) clearance on 1988-09-29 under 510(k) number K883227. 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 SKIFA, PLASTIC DISPOSABLE SYRINGE?

SKIFA, PLASTIC DISPOSABLE SYRINGE is a medical device that received FDA 510(k) clearance on 1988-09-29. The listed applicant is P.T. Setio Harto , Ltd.. The 510(k) number is K883227.

When did SKIFA, PLASTIC DISPOSABLE SYRINGE receive FDA 510(k) clearance?

SKIFA, PLASTIC DISPOSABLE SYRINGE received FDA 510(k) clearance on 1988-09-29, under 510(k) number K883227.

Who is the listed applicant for SKIFA, PLASTIC DISPOSABLE SYRINGE?

The FDA 510(k) record lists P.T. Setio Harto , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKIFA, PLASTIC DISPOSABLE SYRINGE?

The FDA product code for SKIFA, PLASTIC DISPOSABLE 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.

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