FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIELD-LEE BRAIN BIOPSY NEEDLE
K Number: K801760
·
Decision Sep 9, 1980
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
33
Applicant Total
31
Review Days
43
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Basic Information
- Device Name
- FIELD-LEE BRAIN BIOPSY NEEDLE
- K Number
- K801760
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4535
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- American V. Mueller
- Date Received
- July 28, 1980
- Decision Date
- September 9, 1980
- Product Code
- HAO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAO | Instrument, Surgical, Non-Powered | FDA class 1 | Neurology |
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| K854568 | V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP | Dec 2, 1985 | Substantially Equivalent |
| K854049 | HEYER-SCHULTE SYRINGO PERITONEAL SHUNT | Nov 27, 1985 | Substantially Equivalent |
| K851082 | V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES | Jul 22, 1985 | Substantially Equivalent |
| K851974 | V. MUELLER VITAL SKIN STAPLER | Jun 11, 1985 | Substantially Equivalent |