The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Interpore Imz(castable)tub/scret Ret Rigid Attach.
Device ID | K901928 |
510k Number | K901928 |
Device Name: | INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH |
Classification | Attachment, Precision, All |
Applicant | INTERPORE INTL. ABA BIORESEARCH 1700 ROCKVILLE PIKE, SUITE 320 Rockville, MD 20852 |
Contact | Joel S Faden |
Correspondent | Joel S Faden INTERPORE INTL. ABA BIORESEARCH 1700 ROCKVILLE PIKE, SUITE 320 Rockville, MD 20852 |
Product Code | EGG |
CFR Regulation Number | 872.3165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-27 |
Decision Date | 1990-07-26 |