FDA 510(k)

DASS PACK

K-Number: K851280 · 1985-07-05

Decision Date1985-07-05

Product CodeGIF

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

DASS PACK is the device name listed in this FDA 510(k) record. The listed applicant is Dass, Inc.. It received FDA 510(k) clearance on 1985-07-05 under 510(k) number K851280. The device is classified under product code GIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DASS PACK?

DASS PACK is a medical device that received FDA 510(k) clearance on 1985-07-05. The listed applicant is Dass, Inc.. The 510(k) number is K851280.

When did DASS PACK receive FDA 510(k) clearance?

DASS PACK received FDA 510(k) clearance on 1985-07-05, under 510(k) number K851280.

Who is the listed applicant for DASS PACK?

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

What is the FDA product code for DASS PACK?

The FDA product code for DASS PACK is GIF.

Related Devices (Code: GIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.