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FDA 510(k)

MOUTH WASH TRAY

K-Number: K770120 · 1977-01-28

ApplicantPharmaseal Div., Baxter Healthcare Corp.
Decision Date1977-01-28
Product CodeFMA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MOUTH WASH TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaseal Div., Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1977-01-28 under 510(k) number K770120. The device is classified under product code FMA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOUTH WASH TRAY?

MOUTH WASH TRAY is a medical device that received FDA 510(k) clearance on 1977-01-28. The listed applicant is Pharmaseal Div., Baxter Healthcare Corp.. The 510(k) number is K770120.

When did MOUTH WASH TRAY receive FDA 510(k) clearance?

MOUTH WASH TRAY received FDA 510(k) clearance on 1977-01-28, under 510(k) number K770120.

Who is the listed applicant for MOUTH WASH TRAY?

The FDA 510(k) record lists Pharmaseal Div., Baxter Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOUTH WASH TRAY?

The FDA product code for MOUTH WASH TRAY is FMA.

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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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Other records listing Pharmaseal Div., Baxter Healthcare Corp. 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.

K792369HYPERALIMENTATION DRESSING TRAYK792141CONTINUOUS FLUSH DEVICEK792019PHADECODE XA INHIBITOR ASSAYK791773VENTILATOR TUBE WITH FILTERK791156AMIPAQUE MYELOGRAM TRAYK790896TWO-WAY ANESTHESIA FILTER

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Related Devices (Code: FMA)

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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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