Multisurface Roller Bottle (M.S.R.B.)

FDA 510(k) K880509 · Motil Plastics , Ltd.

Substantially Equivalent

510(k) numberK880509

Submission

Device name
Multisurface Roller Bottle (M.S.R.B.)
Applicant
Motil Plastics , Ltd.
Bargoed Mid Glamorga, GB
Received
February 10, 1988
Decision date
April 1, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KJC – Bottle, Roller, Tissue Culture
Device class
Class I (low risk)
Regulation
21 CFR 864.2240
Specialty
Hematology

Other 510(k)s with product code KJC

510(k)DeviceApplicantDecision
K873137In Vitro 2.5X Roller BottleKJC · Traditional In Vitro Scientific Products08/24/1987SE
K791049Synalon Roller BottleKJC · Traditional Dynatech Laboratories, Inc.06/28/1979SE

Questions and answers

When was Multisurface Roller Bottle (M.S.R.B.) cleared by the FDA?

Multisurface Roller Bottle (M.S.R.B.) (K880509) received a 510(k) decision of Substantially Equivalent on April 1, 1988, 51 days after the submission was received.

What is the product code of K880509?

The FDA product code is KJC – Bottle, Roller, Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.