QCR SYSTEM I AND QCR SYSTEM II
FDA 510(k) clearance K893380 · decided 1989-11-16
Clearance details
- K-number
- K893380
- Device name
- QCR SYSTEM I AND QCR SYSTEM II
- Applicant
- Bremer Mfg. & Tool Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-01
- Decision date
- 1989-11-16
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- LGH
- Device class
- 1
- Regulation number
- 888.5960
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Winter Park, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bremer Mfg. & Tool Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (K932653) | Carapace, Inc. | 1994-01-28 |
| CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER (K901677) | Buckman Co., Inc. | 1990-04-23 |
| DELTA-TECH(TM) CAST REMOVAL SYSTEM (K895861) | Johnson & Johnson Professionals, Inc. | 1989-10-19 |
| PLASTER VACUUM, 230V MODEL NO. 4183-161 (K873723) | Martin Medical | 1987-12-10 |
| PLASTER VACUUM, 115V MODEL NO. 4183-160 (K873721) | Martin Medical | 1987-12-07 |
| CAST CUTTER, 115V MODEL NO. 4183-106 (K873719) | Martin Medical | 1987-10-02 |
| CAST CUTTER, 230V MODEL NO. 4183-107 (K873720) | Martin Medical | 1987-10-02 |
| CAST CUTTER/CAST SAW/INSTRUMENT (K820351) | Black & Decker(Tm) | 1982-03-02 |
Recalls involving this device
No recalls on record reference this clearance.