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FDA 510(k)

INDISCAL ASPIRATION DEVICE AND ACCESSORIES

K-Number: K092877 · 2009-11-17

ApplicantBaylis Medical Co., Inc.
Decision Date2009-11-17
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INDISCAL ASPIRATION DEVICE AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Co., Inc.. It received FDA 510(k) clearance on 2009-11-17 under 510(k) number K092877. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDISCAL ASPIRATION DEVICE AND ACCESSORIES?

INDISCAL ASPIRATION DEVICE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2009-11-17. The listed applicant is Baylis Medical Co., Inc.. The 510(k) number is K092877.

When did INDISCAL ASPIRATION DEVICE AND ACCESSORIES receive FDA 510(k) clearance?

INDISCAL ASPIRATION DEVICE AND ACCESSORIES received FDA 510(k) clearance on 2009-11-17, under 510(k) number K092877.

Who is the listed applicant for INDISCAL ASPIRATION DEVICE AND ACCESSORIES?

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

What is the FDA product code for INDISCAL ASPIRATION DEVICE AND ACCESSORIES?

The FDA product code for INDISCAL ASPIRATION DEVICE AND ACCESSORIES is HRX.

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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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