Vac-Rite

FDA 510(k) K770649 · Medical Development Co.

Substantially Equivalent

510(k) numberK770649

Submission

Device name
Vac-Rite
Applicant
Medical Development Co.
Mchenry, IL, US
Received
April 6, 1977
Decision date
June 2, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KDQ – Bottle, Collection, Vacuum
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6740
Specialty
General Hospital

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More from Davol, Inc.

510(k)DeviceDecision
K770758Injection System, MDC I.V.KZD · Traditional 05/20/1977SE

Questions and answers

When was Vac-Rite cleared by the FDA?

Vac-Rite (K770649) received a 510(k) decision of Substantially Equivalent on June 2, 1977, 57 days after the submission was received.

What is the product code of K770649?

The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.