The following data is part of a premarket notification filed by Core-vent Corp. with the FDA for Vent Corp Pib Implant.
Device ID | K873818 |
510k Number | K873818 |
Device Name: | VENT CORP PIB IMPLANT |
Classification | Implant, Endosseous, Root-form |
Applicant | CORE-VENT CORP. 15821 VENTURA BLVD. Encino, CA 91436 |
Contact | Gerald Niznick |
Correspondent | Gerald Niznick CORE-VENT CORP. 15821 VENTURA BLVD. Encino, CA 91436 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-17 |
Decision Date | 1988-02-26 |