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FDA 510(k)

AEROSOL MASKS, 81426, 81476, 81490 & 81492

K-Number: K913220 · 1991-10-10

ApplicantSpecialty Packaging Producs, Inc.
Decision Date1991-10-10
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROSOL MASKS, 81426, 81476, 81490 & 81492 is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Packaging Producs, Inc.. It received FDA 510(k) clearance on 1991-10-10 under 510(k) number K913220. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROSOL MASKS, 81426, 81476, 81490 & 81492?

AEROSOL MASKS, 81426, 81476, 81490 & 81492 is a medical device that received FDA 510(k) clearance on 1991-10-10. The listed applicant is Specialty Packaging Producs, Inc.. The 510(k) number is K913220.

When did AEROSOL MASKS, 81426, 81476, 81490 & 81492 receive FDA 510(k) clearance?

AEROSOL MASKS, 81426, 81476, 81490 & 81492 received FDA 510(k) clearance on 1991-10-10, under 510(k) number K913220.

Who is the listed applicant for AEROSOL MASKS, 81426, 81476, 81490 & 81492?

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

What is the FDA product code for AEROSOL MASKS, 81426, 81476, 81490 & 81492?

The FDA product code for AEROSOL MASKS, 81426, 81476, 81490 & 81492 is CAF.

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Other records listing Specialty Packaging Producs, 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.

K922492SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTERK913163NON REBREATHING VALVEK913422OXYGEN TUBING, 81503K913216TRACH T ADAPTERK913164NON REBREATHING MASKK913421NASAL OXYGEN CANNULA, 81585, 81587 & 81589

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Related Devices (Code: CAF)

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

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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