The following data is part of a premarket notification filed by Bremer Mfg. & Tool Co., Inc. with the FDA for Qcr System I And Qcr System Ii.
| Device ID | K893380 |
| 510k Number | K893380 |
| Device Name: | QCR SYSTEM I AND QCR SYSTEM II |
| Classification | Instrument, Cast Removal, Ac-powered |
| Applicant | BREMER MFG. & TOOL CO., INC. 1455 W FAIRBANKS AVE. POST OFFICE BOX 2894 Winter Park, FL 32790 |
| Contact | Edward Livingston |
| Correspondent | Edward Livingston BREMER MFG. & TOOL CO., INC. 1455 W FAIRBANKS AVE. POST OFFICE BOX 2894 Winter Park, FL 32790 |
| Product Code | LGH |
| CFR Regulation Number | 888.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-01 |
| Decision Date | 1989-11-16 |