DTF-1000LL,DTF-1000
FDA 510(k) clearance K911118 · decided 1991-11-20
Clearance details
- K-number
- K911118
- Device name
- DTF-1000LL,DTF-1000
- Applicant
- Cp Medical
- Decision
- Substantially Equivalent
- Date received
- 1991-03-12
- Decision date
- 1991-11-20
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- EIB
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Huntington Beach, CA, 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 |
|---|---|---|
| MODEL OPO-32 IRRIGATION SLEEVE (K874543) | Allergan, Inc. | 1988-01-14 |
| SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 (K822411) | Western Advanced Technology, Inc. | 1983-07-12 |
| ROBINSON MIDDLE EAR PROSTHESIS (K760570) | Xomed, Inc. | 1976-09-21 |
Recalls involving this device
No recalls on record reference this clearance.