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FDA 510(k)

SAFE-1(TM) SYRINGE

K-Number: K940635 · 1995-01-31

ApplicantSafety 1st Medical, Inc.
Decision Date1995-01-31
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFE-1(TM) SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Safety 1st Medical, Inc.. It received FDA 510(k) clearance on 1995-01-31 under 510(k) number K940635. 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 SAFE-1(TM) SYRINGE?

SAFE-1(TM) SYRINGE is a medical device that received FDA 510(k) clearance on 1995-01-31. The listed applicant is Safety 1st Medical, Inc.. The 510(k) number is K940635.

When did SAFE-1(TM) SYRINGE receive FDA 510(k) clearance?

SAFE-1(TM) SYRINGE received FDA 510(k) clearance on 1995-01-31, under 510(k) number K940635.

Who is the listed applicant for SAFE-1(TM) SYRINGE?

The FDA 510(k) record lists Safety 1st Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE-1(TM) SYRINGE?

The FDA product code for SAFE-1(TM) 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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