FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DTF-1000LL,DTF-1000
K Number: K911118
·
Decision Nov 20, 1991
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
3
Applicant Total
31
Review Days
253
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Basic Information
- Device Name
- DTF-1000LL,DTF-1000
- K Number
- K911118
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Cp Medical
- Date Received
- March 12, 1991
- Decision Date
- November 20, 1991
- Product Code
- EIB
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EIB | Syringe, Irrigating (Dental) | FDA class 1 | Dental |
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| K024372 | CP MEDICAL BONE WAX | Jun 19, 2003 | Substantially Equivalent |
| K030786 | MONO-SWIFT | May 6, 2003 | Substantially Equivalent |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | Mar 28, 2003 | Substantially Equivalent |
| K023710 | VISORB SWIFT | Jan 17, 2003 | Substantially Equivalent |