DTF-1000LL,DTF-1000

FDA 510(k) K911118 · Cp Medical

Substantially Equivalent

510(k) numberK911118

Submission

Device name
DTF-1000LL,DTF-1000
Applicant
Cp Medical
Huntington Beach, CA, US
Received
March 12, 1991
Decision date
November 20, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EIB – Syringe, Irrigating (Dental)
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EIB

510(k)DeviceApplicantDecision
K874543Model OPO-32 Irrigation SleeveEIB · Traditional Allergan, Inc.01/14/1988SE
K822411System 80 Faceplate-In-The-Ear #F1EIB · Traditional Western Advanced Technology, Inc.07/12/1983SE
K760570Robinson Middle Ear ProsthesisEIB · Traditional Xomed, Inc.09/21/1976SE

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Questions and answers

When was DTF-1000LL,DTF-1000 cleared by the FDA?

DTF-1000LL,DTF-1000 (K911118) received a 510(k) decision of Substantially Equivalent on November 20, 1991, 253 days after the submission was received.

What is the product code of K911118?

The FDA product code is EIB – Syringe, Irrigating (Dental), a Class I (low risk) device regulated under 21 CFR 872.4565.