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FDA 510(k)

AXSYM OPIATES

K-Number: K951287 · 1995-05-18

ApplicantAbbott Laboratories
Decision Date1995-05-18
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AXSYM OPIATES is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1995-05-18 under 510(k) number K951287. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXSYM OPIATES?

AXSYM OPIATES is a medical device that received FDA 510(k) clearance on 1995-05-18. The listed applicant is Abbott Laboratories. The 510(k) number is K951287.

When did AXSYM OPIATES receive FDA 510(k) clearance?

AXSYM OPIATES received FDA 510(k) clearance on 1995-05-18, under 510(k) number K951287.

Who is the listed applicant for AXSYM OPIATES?

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

What is the FDA product code for AXSYM OPIATES?

The FDA product code for AXSYM OPIATES is DJG.

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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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