FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRAVES SPECULA
K Number: K821297
·
Decision May 24, 1982
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
10
Applicant Total
122
Review Days
20
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Basic Information
- Device Name
- GRAVES SPECULA
- K Number
- K821297
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4520
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Conphar, Inc.
- Date Received
- May 4, 1982
- Decision Date
- May 24, 1982
- Product Code
- HDF
- 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 |
|---|---|---|---|
| HDF | Speculum, Vaginal, Metal | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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Other Clearances by Conphar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K821825 | CONPHAR SILICONE FEEDING TUBE | Aug 10, 1982 | Substantially Equivalent |
| K821295 | OLSEN HEGAR NEEDLE HOLDERS | Jun 3, 1982 | Substantially Equivalent |
| K821354 | CONPHAR MAYO HEGAR NEEDLE HOLDER | Jun 3, 1982 | Substantially Equivalent |
| K821289 | MAYO-HEGAR NEEDLE HOLDER | Jun 3, 1982 | Substantially Equivalent |
| K821298 | BACKHAUS CLAMP, 3 1/2 | May 28, 1982 | Substantially Equivalent |
| K821285 | SPLINTER FORCEPS 4 1/2 | May 28, 1982 | Substantially Equivalent |
| K821276 | MAYO SCISSOR CURYED 5 1/2 | May 28, 1982 | Substantially Equivalent |
| K821275 | MAYO SCISSOR STRAIGHT 5 1/2 | May 28, 1982 | Substantially Equivalent |
| K821284 | ADSON FORCEPS 4 3/4 | May 28, 1982 | Substantially Equivalent |
| K821248 | ROCHESTER PEAN FORCEPS | May 28, 1982 | Substantially Equivalent |