The following data is part of a premarket notification filed by Hu-friedy Mfg. Co.,inc. with the FDA for Hu-friedy Ims Cassette System.
| Device ID | K844002 |
| 510k Number | K844002 |
| Device Name: | HU-FRIEDY IMS CASSETTE SYSTEM |
| Classification | Tray, Surgical, Instrument |
| Applicant | HU-FRIEDY MFG. CO.,INC. 3232 NORTH ROCKWELL ST. Chicago, IL 60618 |
| Contact | Sarah Liddell |
| Correspondent | Sarah Liddell HU-FRIEDY MFG. CO.,INC. 3232 NORTH ROCKWELL ST. Chicago, IL 60618 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-12 |
| Decision Date | 1984-11-08 |