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FDA 510(k)

ULTRAPAC II SX PLUS (TM)

K-Number: K872657 · 1987-08-04

ApplicantMedical Devices, Inc.
Decision Date1987-08-04
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ULTRAPAC II SX PLUS (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 1987-08-04 under 510(k) number K872657. 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 SX PLUS (TM)?

ULTRAPAC II SX PLUS (TM) is a medical device that received FDA 510(k) clearance on 1987-08-04. The listed applicant is Medical Devices, Inc.. The 510(k) number is K872657.

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

ULTRAPAC II SX PLUS (TM) received FDA 510(k) clearance on 1987-08-04, under 510(k) number K872657.

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

The FDA product code for ULTRAPAC II SX PLUS (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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