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FDA 510(k)

INSUFFLATION NEEDLE

K-Number: K963359 · 1996-09-24

ApplicantApplied Medical Resources
Decision Date1996-09-24
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSUFFLATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1996-09-24 under 510(k) number K963359. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSUFFLATION NEEDLE?

INSUFFLATION NEEDLE is a medical device that received FDA 510(k) clearance on 1996-09-24. The listed applicant is Applied Medical Resources. The 510(k) number is K963359.

When did INSUFFLATION NEEDLE receive FDA 510(k) clearance?

INSUFFLATION NEEDLE received FDA 510(k) clearance on 1996-09-24, under 510(k) number K963359.

Who is the listed applicant for INSUFFLATION NEEDLE?

The FDA 510(k) record lists Applied Medical Resources as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSUFFLATION NEEDLE?

The FDA product code for INSUFFLATION NEEDLE is HET.

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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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