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FDA 510(k)

SURGI-TEK TUBE POSITIONER

K-Number: K863279 · 1986-09-09

ApplicantDermacare Products, Inc.
Decision Date1986-09-09
Product Code
DecisionSubstantially Equivalent

Device Summary

SURGI-TEK TUBE POSITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Dermacare Products, Inc.. It received FDA 510(k) clearance on 1986-09-09 under 510(k) number K863279. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGI-TEK TUBE POSITIONER?

SURGI-TEK TUBE POSITIONER is a medical device that received FDA 510(k) clearance on 1986-09-09. The listed applicant is Dermacare Products, Inc.. The 510(k) number is K863279.

When did SURGI-TEK TUBE POSITIONER receive FDA 510(k) clearance?

SURGI-TEK TUBE POSITIONER received FDA 510(k) clearance on 1986-09-09, under 510(k) number K863279.

Who is the listed applicant for SURGI-TEK TUBE POSITIONER?

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

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Other records listing Dermacare Products, 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.

K882494ELAN-E DISPOSALBE DRAPEK882421INFANT ELECTROSURGICAL DISPERSIVE ELECTRODEK871910SURGITEK DISPOSABLE BIPOLAR CORDK863280DERMAMARKERK863278SURGI-WIPESK862367PRO-CLEAN

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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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