FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CERVICAL SPATULA
K Number: K811548
·
Decision Jun 23, 1981
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
72
Applicant Total
16
Review Days
22
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Basic Information
- Device Name
- CERVICAL SPATULA
- K Number
- K811548
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Procedure Products, Inc.
- Date Received
- June 1, 1981
- Decision Date
- June 23, 1981
- Product Code
- HHT
- 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 |
|---|---|---|---|
| HHT | Spatula, Cervical, Cytological | FDA class 2 | Obstetrics/Gynecology |
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|---|---|---|---|
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| K922536 | TORQUE DEVICE | Dec 10, 1992 | Substantially Equivalent |
| K914128 | CONNECTING SET | Nov 27, 1991 | Substantially Equivalent |
| K910673 | BAG SPIGOT | Apr 24, 1991 | Substantially Equivalent |
| K884985 | MODIFIED 10CC SYRINGE CONTROL RING SET | Dec 20, 1988 | Substantially Equivalent |
| K874747 | 10CC SYRINGE CONTROL RING SET | Feb 4, 1988 | Substantially Equivalent |
| K874037 | ANGIO WASTE FLUIDS DUMP BAG | Jan 29, 1988 | Substantially Equivalent |
| K853749 | CUSTOM CORONARY MANIFOLD KITS | Jan 13, 1986 | Substantially Equivalent |
| K842173 | DISPOSABLE STOPCOCKS | Sep 5, 1984 | Substantially Equivalent |