FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
U. V. GERMICIDAL UNIT
K Number: K871615
·
Decision Sep 11, 1987
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
9
Applicant Total
6
Review Days
137
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Basic Information
- Device Name
- U. V. GERMICIDAL UNIT
- K Number
- K871615
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6870
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Lorvic Corp.
- Date Received
- April 27, 1987
- Decision Date
- September 11, 1987
- Product Code
- KMH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KMH | Sterilizer, Dry Heat | FDA class 2 | General Hospital |
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Other Clearances by Lorvic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K780263 | SHIELD | May 3, 1978 | Substantially Equivalent |
| K770064 | FLUORIDE GEL DISPOSABLE TRAY | Jan 14, 1977 | Substantially Equivalent |
| K770063 | DISP. ABSORBENT COMPRESSED FIBRE WAFER | Jan 14, 1977 | Substantially Equivalent |
| K760620 | SALIVA EJECTOR | Sep 21, 1976 | Substantially Equivalent |
| K760121 | IMPULSE HEAT SEALER | Jul 16, 1976 | Substantially Equivalent |