(56 days)
Ambu Suction Pump is intended for quick suction of fluids from the nose and mouth of children and adult as well as for amnionic fluids from the newborn.
Not Found
This is a 510(k) clearance letter from the FDA for a medical device. It does not include information on acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, not the clearance letter.
Therefore, I cannot provide the requested information based only on the provided text. The document confirms the device is substantially equivalent to a predicate device, which is the basis for its market clearance, but doesn't detail performance studies or acceptance criteria it might have undergone.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 1999
Mr. Sanjay Parikh Manager, Technical and Regulatory Affairs Ambu, Inc. 611 North Hammonds Ferry Road, Suite A Linthicum, Maryland 21090
Re: K992902
Trade Name: Ambu Hand Power Suction Pump. Regulatory Class: I Product Code: BSY, BYY, KTR Dated: August 26, 1999 Received: August 30, 1999
Dear Mr. Parikh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Sanjay Parikh
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device 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) 594-4595. Additionally, for questions on the promotion 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K'992902
Hand Power Portable Suction Unit
Intended Use
Hand Power Portable Suction Unit INDICATION FOR USE
Ambu Suction Pump is intended for quick suction of fluids from the nose and mouth of children and adult as well as for amnionic fluids from the newborn.
colles
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 868.6810 Tracheobronchial suction catheter.
(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.