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FDA 510(k)

MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL

K-Number: K883566 · 1989-09-01

ApplicantMinnetonka, Inc.
Decision Date1989-09-01
Product CodeSEK
DecisionSubstantially Equivalent for Some Indications

Device Summary

MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL is the device name listed in this FDA 510(k) record. The listed applicant is Minnetonka, Inc.. It received FDA 510(k) clearance on 1989-09-01 under 510(k) number K883566. The device is classified under product code SEK. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL?

MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL is a medical device that received FDA 510(k) clearance on 1989-09-01. The listed applicant is Minnetonka, Inc.. The 510(k) number is K883566.

When did MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL receive FDA 510(k) clearance?

MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL received FDA 510(k) clearance on 1989-09-01, under 510(k) number K883566.

Who is the listed applicant for MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL?

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

What is the FDA product code for MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL?

The FDA product code for MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL is SEK.

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 Minnetonka, 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.

K883619MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GELK860843CHECK-UP PLAQUE FIGHTING GUMK831488DAVRON PROF. SCRUB BRUSH-DRY/STERILE

Related Devices (Code: SEK)

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.

K883619MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GELMinnetonka, 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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