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FDA 510(k)

AMNIOSTAT-FLM-PG

K-Number: K061549 · 2006-10-18

ApplicantIrvine Scientific Sales Co., Inc.
Decision Date2006-10-18
Product CodeJHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMNIOSTAT-FLM-PG is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Scientific Sales Co., Inc.. It received FDA 510(k) clearance on 2006-10-18 under 510(k) number K061549. The device is classified under product code JHG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMNIOSTAT-FLM-PG?

AMNIOSTAT-FLM-PG is a medical device that received FDA 510(k) clearance on 2006-10-18. The listed applicant is Irvine Scientific Sales Co., Inc.. The 510(k) number is K061549.

When did AMNIOSTAT-FLM-PG receive FDA 510(k) clearance?

AMNIOSTAT-FLM-PG received FDA 510(k) clearance on 2006-10-18, under 510(k) number K061549.

Who is the listed applicant for AMNIOSTAT-FLM-PG?

The FDA 510(k) record lists Irvine Scientific Sales Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMNIOSTAT-FLM-PG?

The FDA product code for AMNIOSTAT-FLM-PG is JHG.

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Related Devices (Code: JHG)

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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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