Resubmitted Artificial Insemination Instrument Set

FDA 510(k) K884696 · Laboratoire Ccd C/O Washington Regulatory Services

Substantially Equivalent

510(k) numberK884696

Submission

Device name
Resubmitted Artificial Insemination Instrument Set
Applicant
Laboratoire Ccd C/O Washington Regulatory Services
Ringoes, NJ, US
Received
November 9, 1988
Decision date
January 27, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HDR – Cap, Cervical
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5250
Specialty
Obstetrics/Gynecology

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K993953Oves Cervical CapHDR · Traditional Veos , Ltd.03/21/2000SESU
K945131Imagyn Intrauterine Insemination DeviceHDR · Traditional Imagyn Medical, Inc.05/15/1995SE
K950714Cook Insemination CupHDR · Traditional Cook Urological, Inc.05/11/1995SE
K902171Minispace(Tm) Iui CatheterHDR · Traditional Pharmacia, Inc.10/05/1990SE
K902694Coaxial Catheter SetHDR · Traditional Cook Ob/Gyn08/28/1990SE
K896960Intrauterine Insemination CathetersHDR · Traditional C.R. Bard, Inc.06/26/1990SE
K900316Modified Ham's F-10 Medium and Medium-HepesHDR · Traditional Irvine Scientific04/16/1990SE
K900308Sperm Select SystemHDR · Traditional Pharmacia, Inc.04/13/1990SE

More from Pharmacia, Inc.

510(k)DeviceDecision
K890706CytobrushHHT · Traditional 04/25/1989SE
K881456Pipelle de Cornier Endometrial Suction CuretteHHK · Traditional 10/14/1988SE
K881220Endocyte, Disposable Endometrial SamplerHFE · Traditional 06/14/1988SE

Questions and answers

When was Resubmitted Artificial Insemination Instrument Set cleared by the FDA?

Resubmitted Artificial Insemination Instrument Set (K884696) received a 510(k) decision of Substantially Equivalent on January 27, 1989, 79 days after the submission was received.

What is the product code of K884696?

The FDA product code is HDR – Cap, Cervical, a Class II (moderate risk) device regulated under 21 CFR 884.5250.