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FDA 510(k)

ULTRAPAC II SD (TM)

K-Number: K862337 · 1986-08-18

ApplicantMedical Devices, Inc.
Decision Date1986-08-18
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ULTRAPAC II SD (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1986-08-18 under 510(k) number K862337. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAPAC II SD (TM)?

ULTRAPAC II SD (TM) is a medical device that received FDA 510(k) clearance on 1986-08-18. The listed applicant is Medical Devices, Inc.. The 510(k) number is K862337.

When did ULTRAPAC II SD (TM) receive FDA 510(k) clearance?

ULTRAPAC II SD (TM) received FDA 510(k) clearance on 1986-08-18, under 510(k) number K862337.

Who is the listed applicant for ULTRAPAC II SD (TM)?

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

What is the FDA product code for ULTRAPAC II SD (TM)?

The FDA product code for ULTRAPAC II SD (TM) is GZJ.

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Other records listing Medical Devices, Inc. as applicant

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Related Devices (Code: GZJ)

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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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