FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EROSA DISPOSABLE HYPODERMIC NEEDLE
K Number: K853980
·
Decision Oct 18, 1985
Classifications
1
FEI Numbers
321
Registration Numbers
322
Same Product Code
106
Applicant Total
1
Review Days
21
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Basic Information
- Device Name
- EROSA DISPOSABLE HYPODERMIC NEEDLE
- K Number
- K853980
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Rose KG
- Date Received
- September 27, 1985
- Decision Date
- October 18, 1985
- Product Code
- GAA
- 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 |
|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | FDA class 1 | General, Plastic Surgery |
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