The following data is part of a premarket notification filed by Allo Pro Corp. with the FDA for Centering Plug.
Device ID | K900392 |
510k Number | K900392 |
Device Name: | CENTERING PLUG |
Classification | Cement Obturator |
Applicant | ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
Contact | K Pierpoint |
Correspondent | K Pierpoint ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
Product Code | LZN |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-26 |
Decision Date | 1990-03-01 |