FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTAL HAND INSTRUMENTS
K Number: K874964
·
Decision Jan 27, 1988
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
71
Applicant Total
13
Review Days
56
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Basic Information
- Device Name
- DENTAL HAND INSTRUMENTS
- K Number
- K874964
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Solway, Inc.
- Date Received
- December 2, 1987
- Decision Date
- January 27, 1988
- Product Code
- EKJ
- 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 |
|---|---|---|---|
| EKJ | Burnisher, Operative | FDA class 1 | Dental |
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Other Clearances by Solway, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874960 | CARDIOVASCULAR SURGICAL INSTRUMENTS | Feb 5, 1988 | Substantially Equivalent |
| K874962 | FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS | Feb 2, 1988 | Substantially Equivalent |
| K874956 | SELF-RETAINING RETRACTOR FOR NEUROSURGERY | Jan 28, 1988 | Substantially Equivalent |
| K875043 | RONGEUR (NEUROSURGICAL INSTRUMENTS) | Jan 22, 1988 | Substantially Equivalent |
| K874966 | TUNING FORKS | Jan 4, 1988 | Substantially Equivalent |
| K874950 | MICROSURGICAL INSTRUMENTS | Dec 30, 1987 | Substantially Equivalent |
| K874959 | VASCULAR CLAMP | Dec 30, 1987 | Substantially Equivalent |
| K874954 | MANUAL RONGEUR | Dec 30, 1987 | Substantially Equivalent |
| K874952 | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | Dec 30, 1987 | Substantially Equivalent |
| K874965 | MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE | Dec 30, 1987 | Substantially Equivalent |