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FDA 510(k)

BOUNDARY SPECIALTY GOWN

K-Number: K791062 · 1979-06-20

ApplicantProcter & Gamble Mfg. Co.
Decision Date1979-06-20
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOUNDARY SPECIALTY GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Procter & Gamble Mfg. Co.. It received FDA 510(k) clearance on 1979-06-20 under 510(k) number K791062. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOUNDARY SPECIALTY GOWN?

BOUNDARY SPECIALTY GOWN is a medical device that received FDA 510(k) clearance on 1979-06-20. The listed applicant is Procter & Gamble Mfg. Co.. The 510(k) number is K791062.

When did BOUNDARY SPECIALTY GOWN receive FDA 510(k) clearance?

BOUNDARY SPECIALTY GOWN received FDA 510(k) clearance on 1979-06-20, under 510(k) number K791062.

Who is the listed applicant for BOUNDARY SPECIALTY GOWN?

The FDA 510(k) record lists Procter & Gamble Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOUNDARY SPECIALTY GOWN?

The FDA product code for BOUNDARY SPECIALTY GOWN is FYA.

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Other records listing Procter & Gamble Mfg. Co. as applicant

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Related Devices (Code: FYA)

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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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