FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RELIANCE TEMPO OPHTH. INSTR STAND
K Number: K831568
·
Decision Jun 30, 1983
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
5
Applicant Total
9
Review Days
45
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Basic Information
- Device Name
- RELIANCE TEMPO OPHTH. INSTR STAND
- K Number
- K831568
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- F. & F. Koenigkramer
- Date Received
- May 16, 1983
- Decision Date
- June 30, 1983
- Product Code
- HHF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHF), ordered by most recent decision date.
IUD HOOKS
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IUD HOOKS - SIMPLE, UNIVERSAL AND SKLAR
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INTRAUTERINE DEVICE REMOVER
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EMMETT IUD THREAD RETREIVER
FDA 510(k)
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THE EMMETT IUD THREAD RETRIEVER
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by F. & F. Koenigkramer
| K Number | Device Name | ||
|---|---|---|---|
| K860519 | RELIANCE MODEL 200 PODIATRY CHAIR | Feb 19, 1986 | Substantially Equivalent |
| K853149 | RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 | Sep 5, 1985 | Substantially Equivalent |
| K853150 | RELIANCE 6100 | Sep 5, 1985 | Substantially Equivalent |
| K853151 | RELIANCE 5000 | Sep 5, 1985 | Substantially Equivalent |
| K843046 | RELIANCE TREATMENT CABINET | Sep 27, 1984 | Substantially Equivalent |
| K834060 | RELIANCE OPHTHALMIC SLIT LAMP R-083 | Feb 4, 1984 | Substantially Equivalent |
| K812544 | RELIANCE OPHTHALMIC INSTRUMENT CONTROL | Sep 21, 1981 | Substantially Equivalent |
| K761147 | RELIANCE MOD-U-LINE M-700 | Jan 28, 1977 | Substantially Equivalent |