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FDA 510(k)

STERILE PLASTIC DRAPE

K-Number: K913408 · 1992-03-12

ApplicantAcacia Laboratories, Inc.
Decision Date1992-03-12
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE PLASTIC DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Acacia Laboratories, Inc.. It received FDA 510(k) clearance on 1992-03-12 under 510(k) number K913408. 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 STERILE PLASTIC DRAPE?

STERILE PLASTIC DRAPE is a medical device that received FDA 510(k) clearance on 1992-03-12. The listed applicant is Acacia Laboratories, Inc.. The 510(k) number is K913408.

When did STERILE PLASTIC DRAPE receive FDA 510(k) clearance?

STERILE PLASTIC DRAPE received FDA 510(k) clearance on 1992-03-12, under 510(k) number K913408.

Who is the listed applicant for STERILE PLASTIC DRAPE?

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

What is the FDA product code for STERILE PLASTIC DRAPE?

The FDA product code for STERILE PLASTIC DRAPE is KKX.

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Other records listing Acacia Laboratories, 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.

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Related Devices (Code: KKX)

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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