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FDA 510(k)

BOUNDARY HEADWEAR

K-Number: K831357 · 1983-06-02

ApplicantProcter & Gamble Mfg. Co.
Decision Date1983-06-02
Product CodeFYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOUNDARY HEADWEAR 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 1983-06-02 under 510(k) number K831357. The device is classified under product code FYF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOUNDARY HEADWEAR?

BOUNDARY HEADWEAR is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Procter & Gamble Mfg. Co.. The 510(k) number is K831357.

When did BOUNDARY HEADWEAR receive FDA 510(k) clearance?

BOUNDARY HEADWEAR received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831357.

Who is the listed applicant for BOUNDARY HEADWEAR?

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 HEADWEAR?

The FDA product code for BOUNDARY HEADWEAR is FYF.

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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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Related Devices (Code: FYF)

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.

K972227SHOE COVERAmerican Seal Co.K955833NIOMED SURGICAL CAPSAmerasia Corp.K954556SURGICAL CAPThai Disposable Products Co., Ltd.K954454NIOMED SURGICAL HOODAmerasia Corp.K954455NIOMED BOUFFANT CAPSAmerasia Corp.K953878BOUFFANT CAPAmerican Threshold Industries, Inc.

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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