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FDA 510(k)

OP-SITE ADHESIVE DRAPES

K-Number: K780853 · 1978-08-14

ApplicantAcme United Corp.
Decision Date1978-08-14
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OP-SITE ADHESIVE DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Acme United Corp.. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K780853. 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 OP-SITE ADHESIVE DRAPES?

OP-SITE ADHESIVE DRAPES is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Acme United Corp.. The 510(k) number is K780853.

When did OP-SITE ADHESIVE DRAPES receive FDA 510(k) clearance?

OP-SITE ADHESIVE DRAPES received FDA 510(k) clearance on 1978-08-14, under 510(k) number K780853.

Who is the listed applicant for OP-SITE ADHESIVE DRAPES?

The FDA 510(k) record lists Acme United Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OP-SITE ADHESIVE DRAPES?

The FDA product code for OP-SITE ADHESIVE DRAPES is KKX.

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Other records listing Acme United Corp. as applicant

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Related Devices (Code: KKX)

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K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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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