FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
K Number: K855003
·
Decision Feb 10, 1986
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
206
Review Days
59
Basic Information
- Device Name
- BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
- K Number
- K855003
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Travenol Laboratories, S.A.
- Date Received
- December 13, 1985
- Decision Date
- February 10, 1986
- Product Code
- KNW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K871908 | IV ADMINISTRATION SET | Jul 27, 1987 | Substantially Equivalent |
| K871471 | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 | Jun 12, 1987 | Substantially Equivalent |
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