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FDA 510(k)

PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE

K-Number: K863366 · 1986-11-21

ApplicantLabeltape Meditect, Inc.
Decision Date1986-11-21
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE is the device name listed in this FDA 510(k) record. The listed applicant is Labeltape Meditect, Inc.. It received FDA 510(k) clearance on 1986-11-21 under 510(k) number K863366. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE?

PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE is a medical device that received FDA 510(k) clearance on 1986-11-21. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K863366.

When did PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE receive FDA 510(k) clearance?

PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE received FDA 510(k) clearance on 1986-11-21, under 510(k) number K863366.

Who is the listed applicant for PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE?

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

What is the FDA product code for PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE?

The FDA product code for PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE is DRX.

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Other records listing Labeltape Meditect, Inc. as applicant

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Related Devices (Code: DRX)

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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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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