(122 days)
This is intended to enclose medical devices that are to be sterilized in a health care facility. The tray is intended to allow steam to penetrate to the enclosed medical devices.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a "Dental Sterilization Tray/Cassette". This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. It primarily addresses the regulatory classification and premarket notification status of the device, confirming its substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the given text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Brassler USA® C/O Ms. Courtney S. Paradice 1679 Kellog Springs Drive Atlanta, Georgia 30338
Re : K983223 Dental Sterilization Tray/Cassette Trade Name: Regulatory Class: II Product Code: FRG October 30, 1998 Dated: Received: November 9, 1998
Dear Ms. Paradice:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beccron six ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . market the device reflicancy (for the indications for device is subscanciary ore) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enactment date or the nassified in accordance with the devices that have been roofood, Drug, and Cosmetic the esperal provisions of the reactar rood, asubject to the general The general controls controls provisions of the Act. controls provisions of include requirements for annual provisions of the Act increase requeed manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major be subject to back addroundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੋ rederal Regulation, and determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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through 542 of the Act for devices under the Electronic Chrough J42 Of the not is provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as Inis recei wire arrowk) premarket notification. The FDA described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate device assubsite to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compreation and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from cho rumber (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Ulatowski I'ima A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510(k) Number (if known): K983223:
Device Name: Surgical / dental sterilization tray
Indications For Use:
Thi is intended enclose dica m that આવે terilized ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻷ health care ત્વ L + ende ه ه allow to sed medical
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Office of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Neuse 1. Melle fer Rius.
O
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K983223
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).