FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ETHICON EXTERNAL FIXATION WIRE
K Number: K821178
·
Decision Jun 11, 1983
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
204
Review Days
410
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Basic Information
- Device Name
- ETHICON EXTERNAL FIXATION WIRE
- K Number
- K821178
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3250
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- ETHICON, Inc.
- Date Received
- April 27, 1982
- Decision Date
- June 11, 1983
- Product Code
- FYI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FYI | Appliance, Facial Fracture, External | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FYI), ordered by most recent decision date.
OMEGA BIVALVE NASAL SPLINTS
FDA 510(k)
FDA Class 1
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STRAITH NASAL SPLINT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CONPHAR O.R. HEAD COVER-STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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