Premarket notification, 510(k)
Subtitle: regulatory requirements for medical devices
By: prepared by Division of Small Manufacturers Assistance, Office of Training and Assistance
Series: Medical devices; HHS publication -- FDA 90-4158; HHS publication -- no. (FDA) 90-4158
Publisher: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health; For sale by the Supt. of Docs., U.S. G.P.O.
Published: 1990
Place of publication: Rockville, Md; Washington, D.C
Language: eng
Number of pages: 69
Subjects: Equipment and Supplies; Standards; Medical instruments and apparatus; Safety regulations; Consumer Product Safety; Guideline; Legislation; Equipment Safety
Other titles: Regulatory requirements for medical devices.
Notes: "August 1990."

"Supercedes [sic] FDA 89-4158."

Shipping list no.: 90-518-P.

Includes bibliographical references.