FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FILTER UNIT, SINGLE USE
K Number: K770703
·
Decision Jun 14, 1977
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
30
Review Days
57
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Basic Information
- Device Name
- FILTER UNIT, SINGLE USE
- K Number
- K770703
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Millipore Corp.
- Date Received
- April 18, 1977
- Decision Date
- June 14, 1977
- Product Code
- FPB
- 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 |
|---|---|---|---|
| FPB | Filter, Infusion Line | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K941326 | ULTRAFREE-CL | May 27, 1994 | Substantially Equivalent |
| K934069 | MILLEX, DUALEX (PLUS, ULTRA) | Apr 21, 1994 | Substantially Equivalent |
| K924347 | WATERS(TM) 996 PDA | Dec 11, 1992 | Substantially Equivalent |
| K922388 | WATERS(TM) LC MODULE I FOR CLINICAL USE | Sep 11, 1992 | Substantially Equivalent |
| K920136 | WATERS 717 AUTOSAMPLER | Feb 19, 1992 | Substantially Equivalent |
| K914841 | CHROMATOGRAPHY CLINICAL USE 75JQR | Dec 10, 1991 | Substantially Equivalent |
| K903647 | MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE | Sep 11, 1990 | Substantially Equivalent |