FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIFINE PENTIPS
K Number: K973899
·
Decision Dec 4, 1997
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
10
Review Days
51
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Basic Information
- Device Name
- UNIFINE PENTIPS
- K Number
- K973899
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Owen Mumford USA, Inc.
- Date Received
- October 14, 1997
- Decision Date
- December 4, 1997
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Owen Mumford USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013362 | AUTOJECT 2 | Nov 13, 2001 | Substantially Equivalent |
| K993385 | AUTOJET 2 (NON-FIXED NEEDLE TYPE) | Nov 10, 1999 | Substantially Equivalent |
| K983994 | UNIFINE | Jan 8, 1999 | Substantially Equivalent |
| K983974 | OWEN MUMFORD 3ML AUTOPEN | Dec 21, 1998 | Substantially Equivalent |
| K982275 | RAPPORT V.T.D. | Dec 4, 1998 | Substantially Equivalent |
| K983045 | AMIELLE | Nov 25, 1998 | Substantially Equivalent |
| K971443 | RAPPORT V.T.D. | Sep 26, 1997 | Substantially Equivalent |
| K953735 | AUTOJECT MINI | Nov 8, 1995 | Substantially Equivalent |
| K945660 | AUTOJECT 2 | Aug 11, 1995 | Substantially Equivalent |