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FDA 510(k)

DILATING TIP OBTURATOR

K-Number: K012884 · 2002-01-17

ApplicantApplied Medical Resources Corp.
Decision Date2002-01-17
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DILATING TIP OBTURATOR is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2002-01-17 under 510(k) number K012884. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DILATING TIP OBTURATOR?

DILATING TIP OBTURATOR is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K012884.

When did DILATING TIP OBTURATOR receive FDA 510(k) clearance?

DILATING TIP OBTURATOR received FDA 510(k) clearance on 2002-01-17, under 510(k) number K012884.

Who is the listed applicant for DILATING TIP OBTURATOR?

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

What is the FDA product code for DILATING TIP OBTURATOR?

The FDA product code for DILATING TIP OBTURATOR is GCJ.

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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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