The following data is part of a premarket notification filed by Hu-friedy Mfg. Co.,inc. with the FDA for Accu-placer Tm Kit.
| Device ID | K912473 |
| 510k Number | K912473 |
| Device Name: | ACCU-PLACER TM KIT |
| Classification | Burnisher, Operative |
| Applicant | HU-FRIEDY MFG. CO.,INC. 3232 NORTH ROCKWELL ST. Chicago, IL 60618 |
| Contact | Betsy A Brown |
| Correspondent | Betsy A Brown HU-FRIEDY MFG. CO.,INC. 3232 NORTH ROCKWELL ST. Chicago, IL 60618 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-04 |
| Decision Date | 1991-07-24 |