The following data is part of a premarket notification filed by Biological Rescue Products, Inc. with the FDA for Tooth Preserving System.
Device ID | K875221 |
510k Number | K875221 |
Device Name: | TOOTH PRESERVING SYSTEM |
Classification | System, Suspension, Cell Culture |
Applicant | BIOLOGICAL RESCUE PRODUCTS, INC. 22 N. PRICE ST. Pottstown, PA 19464 |
Contact | Paul Krasner |
Correspondent | Paul Krasner BIOLOGICAL RESCUE PRODUCTS, INC. 22 N. PRICE ST. Pottstown, PA 19464 |
Product Code | KJF |
CFR Regulation Number | 864.2240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-22 |
Decision Date | 1988-04-14 |