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FDA 510(k)

PANOGAUZE NON-WOVEN HYDROGEL DRESSING

K-Number: K964620 · 1997-01-09

ApplicantSage Pharmaceuticals, Inc.
Decision Date1997-01-09
Product CodeMGQ
DecisionSubstantially Equivalent for Some Indications

Device Summary

PANOGAUZE NON-WOVEN HYDROGEL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Sage Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1997-01-09 under 510(k) number K964620. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PANOGAUZE NON-WOVEN HYDROGEL DRESSING?

PANOGAUZE NON-WOVEN HYDROGEL DRESSING is a medical device that received FDA 510(k) clearance on 1997-01-09. The listed applicant is Sage Pharmaceuticals, Inc.. The 510(k) number is K964620.

When did PANOGAUZE NON-WOVEN HYDROGEL DRESSING receive FDA 510(k) clearance?

PANOGAUZE NON-WOVEN HYDROGEL DRESSING received FDA 510(k) clearance on 1997-01-09, under 510(k) number K964620.

Who is the listed applicant for PANOGAUZE NON-WOVEN HYDROGEL DRESSING?

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

What is the FDA product code for PANOGAUZE NON-WOVEN HYDROGEL DRESSING?

The FDA product code for PANOGAUZE NON-WOVEN HYDROGEL DRESSING is MGQ.

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Other records listing Sage Pharmaceuticals, Inc. as applicant

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.

K945005PANOPLEX HYDROGEL WOUND DRESSING

Related Devices (Code: MGQ)

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.

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