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FDA 510(k)

ABCO PLASTIC UTENSILS

K-Number: K851309 · 1985-07-01

ApplicantAbco Dealers, Inc.
Decision Date1985-07-01
Product CodeKTC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ABCO PLASTIC UTENSILS is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1985-07-01 under 510(k) number K851309. The device is classified under product code KTC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABCO PLASTIC UTENSILS?

ABCO PLASTIC UTENSILS is a medical device that received FDA 510(k) clearance on 1985-07-01. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K851309.

When did ABCO PLASTIC UTENSILS receive FDA 510(k) clearance?

ABCO PLASTIC UTENSILS received FDA 510(k) clearance on 1985-07-01, under 510(k) number K851309.

Who is the listed applicant for ABCO PLASTIC UTENSILS?

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

What is the FDA product code for ABCO PLASTIC UTENSILS?

The FDA product code for ABCO PLASTIC UTENSILS is KTC.

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Other records listing Abco Dealers, 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.

K905025DIGITAL THERMOMETER KITSK882304DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)K880892BLOOD COLLECTING NEEDLE AND HOLDERSK880894ALLERGIST SYRINGESK872875STRETCH GAUZE BANDAGESK872874MICROSCOPE COVER GLASSES

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Related Devices (Code: KTC)

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.

K912179THE SPRITZ BATHThe Spritz Co.K890085SIT-N-BATHE SITZ BATHDrummond Industries, Inc.K862600SITZ BATHW. C. Green, D.D.S.K841711MAC LEE SITZ BATHMac Lee Medical ProductsK831762SITZ BATH, SINGLE PATIENT USE #8100Lsl Industries, Inc.K800958PERSONAL SITZ BATH KITThe Healthcare Group Laboratories, 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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