FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PISTON SYRINGE WITH NEEDLE
K Number: K883033
·
Decision Oct 31, 1988
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
7
Review Days
104
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Basic Information
- Device Name
- PISTON SYRINGE WITH NEEDLE
- K Number
- K883033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Select Sources, Inc.
- Date Received
- July 19, 1988
- Decision Date
- October 31, 1988
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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Other Clearances by Select Sources, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884328 | CHOICE ALSO ORIENT SURGICAL GLOVES (STERILE) | Apr 26, 1989 | Substantially Equivalent |
| K883705 | FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS | Nov 14, 1988 | Substantially Equivalent |
| K883078 | INSULIN SYRINGE | Oct 31, 1988 | Substantially Equivalent |
| K880919 | (CHOICE) ALSO (KONDUM) | Jun 29, 1988 | Substantially Equivalent |
| K864482 | CHOICE | Dec 22, 1986 | Substantially Equivalent |
| K863190 | CHOICE CONDOM | Dec 3, 1986 | Substantially Equivalent |