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FDA 510(k)

BOUNDARY SINGLE-USE GOWNS

K-Number: K841255 · 1984-04-25

ApplicantProcter & Gamble Mfg. Co.
Decision Date1984-04-25
Product Code
DecisionSubstantially Equivalent

Device Summary

BOUNDARY SINGLE-USE GOWNS 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 1984-04-25 under 510(k) number K841255. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOUNDARY SINGLE-USE GOWNS?

BOUNDARY SINGLE-USE GOWNS is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Procter & Gamble Mfg. Co.. The 510(k) number is K841255.

When did BOUNDARY SINGLE-USE GOWNS receive FDA 510(k) clearance?

BOUNDARY SINGLE-USE GOWNS received FDA 510(k) clearance on 1984-04-25, under 510(k) number K841255.

Who is the listed applicant for BOUNDARY SINGLE-USE GOWNS?

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

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Other records listing Procter & Gamble Mfg. Co. 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.

K873457SCENTED OR SCENTED DEODORIZED MENSTRUAL PADSK873036ATTENDS INCONTINENT BRIEFK864673UNSCENTED MENSTRUAL PADK861863MODIFIED PROTECTIVE GARMENTK862348SINGLE-USE PATIENT UNDERPADK860598MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS

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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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