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FDA 510(k)

MOUTH-TO-MOUTH SHIELD APPLICATOR

K-Number: K832590 · 1983-10-14

ApplicantMem, Inc.
Decision Date1983-10-14
Product CodeLAE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MOUTH-TO-MOUTH SHIELD APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mem, Inc.. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832590. The device is classified under product code LAE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOUTH-TO-MOUTH SHIELD APPLICATOR?

MOUTH-TO-MOUTH SHIELD APPLICATOR is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Mem, Inc.. The 510(k) number is K832590.

When did MOUTH-TO-MOUTH SHIELD APPLICATOR receive FDA 510(k) clearance?

MOUTH-TO-MOUTH SHIELD APPLICATOR received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832590.

Who is the listed applicant for MOUTH-TO-MOUTH SHIELD APPLICATOR?

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

What is the FDA product code for MOUTH-TO-MOUTH SHIELD APPLICATOR?

The FDA product code for MOUTH-TO-MOUTH SHIELD APPLICATOR is LAE.

Related Clinical Trials

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 Mem, 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.

K842599METER MOUSE SYSTEM

Related Devices (Code: LAE)

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.

K851480VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRWVygon Corp.

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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