FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
PHARMA-PLAST NEEDLE
K Number: K852442
·
Decision Sep 20, 1985
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
9
Review Days
102
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Basic Information
- Device Name
- PHARMA-PLAST NEEDLE
- K Number
- K852442
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pharma-Plast USA, Inc.
- Date Received
- June 10, 1985
- Decision Date
- September 20, 1985
- 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 Pharma-Plast USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K894371 | NIPRO SAFELET CATH | Oct 25, 1989 | Substantially Equivalent |
| K894373 | NIPRO DENTAL NEEDLE | Oct 13, 1989 | Substantially Equivalent |
| K894374 | BLOOD DRAWING NEEDLE | Sep 28, 1989 | Substantially Equivalent |
| K894372 | NIPRO NEEDLE HOLDER | Sep 28, 1989 | Substantially Equivalent |
| K884978 | PHARMA-PLAST INSULIN INFUSION SET | Jun 21, 1989 | Substantially Equivalent |
| K871263 | MULTIPLE PHARMA-PLAST TRACHEAL TUBE | Jun 15, 1987 | Substantially Equivalent |
| K852444 | ASIK 'ONCE' SYRINGE | Oct 16, 1985 | Substantially Equivalent |
| K852443 | PHARMA-PLAST CLINIPAK | Oct 16, 1985 | Substantially Equivalent |