FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VACU-FIL TRANSFER SET
K Number: K812928
·
Decision Dec 30, 1981
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
64
Review Days
72
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Basic Information
- Device Name
- VACU-FIL TRANSFER SET
- K Number
- K812928
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- American Pharmaseal Div. Ahsc
- Date Received
- October 19, 1981
- Decision Date
- December 30, 1981
- Product Code
- LHI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K871429 | ANTIMICROBIAL FOLEY CATHETER | Aug 10, 1987 | Substantially Equivalent |
| K871770 | AMERICAN PHARMASEAL WOUND DRESSING | Jun 26, 1987 | Substantially Equivalent for Some Indications |
| K870387 | EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE | May 8, 1987 | Substantially Equivalent |
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