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FDA 510(k)

DISPOSABLE SKIN MARKING PEN

K-Number: K843116 · 1984-08-17

ApplicantE.M. Adams
Decision Date1984-08-17
Product CodeFZZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SKIN MARKING PEN is the device name listed in this FDA 510(k) record. The listed applicant is E.M. Adams. It received FDA 510(k) clearance on 1984-08-17 under 510(k) number K843116. The device is classified under product code FZZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE SKIN MARKING PEN?

DISPOSABLE SKIN MARKING PEN is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is E.M. Adams. The 510(k) number is K843116.

When did DISPOSABLE SKIN MARKING PEN receive FDA 510(k) clearance?

DISPOSABLE SKIN MARKING PEN received FDA 510(k) clearance on 1984-08-17, under 510(k) number K843116.

Who is the listed applicant for DISPOSABLE SKIN MARKING PEN?

The FDA 510(k) record lists E.M. Adams as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE SKIN MARKING PEN?

The FDA product code for DISPOSABLE SKIN MARKING PEN is FZZ.

Related Clinical Trials

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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Other records listing E.M. Adams 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.

K905173SPLASH GUARDK910468STERILE DISPOSABLE DRAPE(S)K873978DISPOSABLE BIPOLAR FORCEPSK850063INSTRUMENT POCKETK843724I.V. START KIT & OBSTETRICAL KITK843783WET PACK

View all 21 devices →

Related Devices (Code: FZZ)

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.

K042555SURGICHIP TAG SURGICAL MARKERSurgichip, Inc.K915066DISPOSABLE SKIN MARKERAmerican Medical Mfg., Inc.K914759BLOOM TRANSPARENT STENCILFreckles Publications, Inc.K912730ROCKET SURGICAL SKIN MARKING PENWest Texas Lighthouse For the BlindK905143SKIN MARKERAesculap, Inc.K904559QUALTEX SKIN MARKERQualtex, 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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