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FDA 510(k)

PACH-PEN SURGICAL DRAPE

K-Number: K862016 · 1986-06-04

ApplicantOculab, Inc.
Decision Date1986-06-04
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PACH-PEN SURGICAL DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Oculab, Inc.. It received FDA 510(k) clearance on 1986-06-04 under 510(k) number K862016. 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 PACH-PEN SURGICAL DRAPE?

PACH-PEN SURGICAL DRAPE is a medical device that received FDA 510(k) clearance on 1986-06-04. The listed applicant is Oculab, Inc.. The 510(k) number is K862016.

When did PACH-PEN SURGICAL DRAPE receive FDA 510(k) clearance?

PACH-PEN SURGICAL DRAPE received FDA 510(k) clearance on 1986-06-04, under 510(k) number K862016.

Who is the listed applicant for PACH-PEN SURGICAL DRAPE?

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

What is the FDA product code for PACH-PEN SURGICAL DRAPE?

The FDA product code for PACH-PEN SURGICAL DRAPE is KKX.

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Other records listing Oculab, 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.

K884619PACH-PEN CALCULATORK882750OCU-FILM TIP COVERK860205BIO-PEN CALCULATORK860061OCULAB BIOMETRICPENK860062OCULAB PACHPENK852774OCULAB TONOPEN

View all 7 devices →

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.

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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