FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BONE RONGEUR, DOUBLE-ACTION
K Number: K890256
·
Decision Jan 27, 1989
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
7
Applicant Total
63
Review Days
9
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Basic Information
- Device Name
- BONE RONGEUR, DOUBLE-ACTION
- K Number
- K890256
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kinetic Medical Products
- Date Received
- January 18, 1989
- Decision Date
- January 27, 1989
- Product Code
- EMH
- 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 |
|---|---|---|---|
| EMH | Forceps, Rongeur, Surgical | FDA class 1 | Dental |
Similar 510(k) Clearances
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Other Clearances by Kinetic Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K890385 | MIDWIFERY/OBSTETRICAL FORCEPS | Mar 1, 1989 | Substantially Equivalent |
| K890387 | MALLEABLE PLACENTA CURETTE | Feb 27, 1989 | Substantially Equivalent |
| K890380 | CERVICAL BIOPSY FORCEPS | Feb 27, 1989 | Substantially Equivalent |
| K890382 | COMPRESSION FORCEPS | Feb 27, 1989 | Substantially Equivalent |
| K890376 | VAGINAL SPECULUM | Feb 27, 1989 | Substantially Equivalent |
| K890383 | HYSTERECTOMY FORCEPS | Feb 16, 1989 | Substantially Equivalent |
| K890216 | MICROSURGICAL KERATOME | Feb 16, 1989 | Substantially Equivalent |
| K890378 | UTERINE DRESSING FORCEPS | Feb 13, 1989 | Substantially Equivalent |
| K890379 | UTERINE TENTACULUM | Feb 13, 1989 | Substantially Equivalent |
| K890389 | UMBILICAL SCISSORS | Feb 13, 1989 | Substantially Equivalent |