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FDA 510(k)

HYPODERMIC NEEDLES & SYRINGES

K-Number: K821348 · 1982-06-10

ApplicantMedi-Tech, Inc.
Decision Date1982-06-10
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYPODERMIC NEEDLES & SYRINGES is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Tech, Inc.. It received FDA 510(k) clearance on 1982-06-10 under 510(k) number K821348. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPODERMIC NEEDLES & SYRINGES?

HYPODERMIC NEEDLES & SYRINGES is a medical device that received FDA 510(k) clearance on 1982-06-10. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K821348.

When did HYPODERMIC NEEDLES & SYRINGES receive FDA 510(k) clearance?

HYPODERMIC NEEDLES & SYRINGES received FDA 510(k) clearance on 1982-06-10, under 510(k) number K821348.

Who is the listed applicant for HYPODERMIC NEEDLES & SYRINGES?

The FDA 510(k) record lists Medi-Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPODERMIC NEEDLES & SYRINGES?

The FDA product code for HYPODERMIC NEEDLES & SYRINGES is GAA.

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Related Devices (Code: GAA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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