The following data is part of a premarket notification filed by Magnum Instruments, Inc. with the FDA for Stat Pak.
| Device ID | K943820 |
| 510k Number | K943820 |
| Device Name: | STAT PAK |
| Classification | Burnisher, Operative |
| Applicant | MAGNUM INSTRUMENTS, INC. 1935 BRANDON CT., UNIT B Glendale Hts., IL 60139 |
| Contact | John Hamid |
| Correspondent | John Hamid MAGNUM INSTRUMENTS, INC. 1935 BRANDON CT., UNIT B Glendale Hts., IL 60139 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-05 |
| Decision Date | 1994-11-02 |