FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REDYPLATE DISPOSABLE LEG PLATE
K Number: K901152
·
Decision Apr 4, 1990
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
16
Applicant Total
3
Review Days
22
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Basic Information
- Device Name
- REDYPLATE DISPOSABLE LEG PLATE
- K Number
- K901152
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2675
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Medical Accessories, Inc.
- Date Received
- March 13, 1990
- Decision Date
- April 4, 1990
- Product Code
- HGP
- 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 |
|---|---|---|---|
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | FDA class 2 | Obstetrics/Gynecology |
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