DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21
FDA 510(k) clearance K911120 · decided 1994-02-03
Clearance details
- K-number
- K911120
- Device name
- DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21
- Applicant
- Hamo USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-11
- Decision date
- 1994-02-03
- Days to decision
- 1060 days
- Clearance type
- Traditional
- Product code
- MEC
- Device class
- 2
- Regulation number
- 880.6992
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 (K081094) | Olympic Medical Corp. | 2008-06-20 |
Recalls involving this device
No recalls on record reference this clearance.