FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PAVLIK HARNESS
K Number: K780375
·
Decision Mar 15, 1978
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
3
Applicant Total
441
Review Days
7
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Basic Information
- Device Name
- PAVLIK HARNESS
- K Number
- K780375
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3665
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Biomet, Inc.
- Date Received
- March 8, 1978
- Decision Date
- March 15, 1978
- Product Code
- IOZ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IOZ | Splint, Abduction, Congenital Hip Dislocation | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IOZ), ordered by most recent decision date.
ABDUCTION PILLOW
FDA 510(k)
FDA Class 1
·Physical Medicine
ABDUCTION PILLOW
FDA 510(k)
FDA Class 1
·Physical Medicine
HIP ABDUCTION SPLINT
FDA 510(k)
FDA Class 1
·Physical Medicine
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