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FDA 510(k)

BOUNDARY SINGLE-USE DRAPE

K-Number: K802148 · 1980-09-26

ApplicantProcter & Gamble Mfg. Co.
Decision Date1980-09-26
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOUNDARY SINGLE-USE DRAPE 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 1980-09-26 under 510(k) number K802148. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOUNDARY SINGLE-USE DRAPE?

BOUNDARY SINGLE-USE DRAPE is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Procter & Gamble Mfg. Co.. The 510(k) number is K802148.

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

BOUNDARY SINGLE-USE DRAPE received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802148.

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

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 SINGLE-USE DRAPE?

The FDA product code for BOUNDARY SINGLE-USE DRAPE is KKX.

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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.

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Related Devices (Code: KKX)

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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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