Sterile Disposable Drape(S)

FDA 510(k) K910468 · E.M. Adams

Substantially Equivalent

510(k) numberK910468

Submission

Device name
Sterile Disposable Drape(S)
Applicant
E.M. Adams
Medfield, MA, US
Received
February 4, 1991
Decision date
March 21, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FZI – Apparatus, Air Handling, Enclosure
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5070
Specialty
General, Plastic Surgery

Other 510(k)s with product code FZI

510(k)DeviceApplicantDecision
K911132Multiple, Surgical Drape PackFZI · Traditional Central Georgia Ancillary Health Systems05/06/1991SE
K854159Ellipti-PunchFZI · Traditional Alcon Laboratories11/15/1985SE
K772395Davis RhytidectomyFZI · Traditional Edward Weck, Inc.03/09/1978SE
K772394Kalrn Face-Life ScissorsFZI · Traditional Edward Weck, Inc.03/09/1978SE

More from Edward Weck, Inc.

510(k)DeviceDecision
K971948Patient RestraintFMQ · Traditional 08/06/1997SE
K971536Restraints (Vests and Jackets)FMQ · Traditional 07/01/1997SE
K905173Splash GuardKYZ · Traditional 04/25/1991SE
K873978Disposable Bipolar ForcepsGEN · Traditional 11/23/1987SE
K850063Instrument Pocket · Traditional 02/21/1985SE
K843724I.V. Start Kit & Obstetrical KitKKX · Traditional 01/10/1985SE
K843783Wet PackEFQ · Traditional 12/19/1984SE
K843782Dry TrayEFQ · Traditional 12/13/1984SE
K843723Sterile Instrument Trays-VariousFSM · Traditional 10/23/1984SE
K843115Sterile Solution BowlKDD · Traditional 09/07/1984SE

Questions and answers

When was Sterile Disposable Drape(S) cleared by the FDA?

Sterile Disposable Drape(S) (K910468) received a 510(k) decision of Substantially Equivalent on March 21, 1991, 45 days after the submission was received.

What is the product code of K910468?

The FDA product code is FZI – Apparatus, Air Handling, Enclosure, a Class II (moderate risk) device regulated under 21 CFR 878.5070.