FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LARES AIR PRESSURE GAUGE
K Number: K801534
·
Decision Jul 14, 1980
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
6
Review Days
11
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Basic Information
- Device Name
- LARES AIR PRESSURE GAUGE
- K Number
- K801534
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Lares Manufacturing Co., Inc.
- Date Received
- July 3, 1980
- Decision Date
- July 14, 1980
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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Other Clearances by Lares Manufacturing Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K831351 | PERMALUX VISIBLE CURE COMPOSITE RESTOR | Nov 14, 1983 | Substantially Equivalent |
| K801535 | LARES HANDPIECE OIL | Dec 16, 1980 | Substantially Equivalent |
| K801592 | FIBER OPTIC HOSE | Jul 21, 1980 | Substantially Equivalent |
| K801591 | FIBER OPTIC ILLUMINATOR | Jul 21, 1980 | Substantially Equivalent |
| K780038 | DENTAL HANDPIECE | Jan 20, 1978 | Substantially Equivalent |