The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Interpore Threaded Implant.
Device ID | K960371 |
510k Number | K960371 |
Device Name: | INTERPORE THREADED IMPLANT |
Classification | Implant, Endosseous, Root-form |
Applicant | INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
Contact | David P Balding |
Correspondent | David P Balding INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-26 |
Decision Date | 1996-03-08 |
Summary: | summary |