FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MRI SAFE INSTRUMENTS
K Number: K003965
·
Decision Mar 16, 2001
Classifications
1
FEI Numbers
378
Registration Numbers
378
Same Product Code
35
Applicant Total
207
Review Days
84
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Basic Information
- Device Name
- MRI SAFE INSTRUMENTS
- K Number
- K003965
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap, Inc.
- Date Received
- December 22, 2000
- Decision Date
- March 16, 2001
- Product Code
- GEA
- 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 |
|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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ORIGIN SECONDARY CANNULA AND TROCAR
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ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE
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DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
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DISPOSABLE YANKAUER SUCTION TUBE
FDA 510(k)
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