FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
PHARMA-PLAST INSULIN INFUSION SET
K Number: K884978
·
Decision Jun 21, 1989
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
83
Applicant Total
9
Review Days
203
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Basic Information
- Device Name
- PHARMA-PLAST INSULIN INFUSION SET
- K Number
- K884978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pharma-Plast USA, Inc.
- Date Received
- November 30, 1988
- Decision Date
- June 21, 1989
- Product Code
- LZG
- 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 |
|---|---|---|---|
| LZG | Pump, Infusion, Insulin | 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 |
| 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 |
| K852442 | PHARMA-PLAST NEEDLE | Sep 20, 1985 | Substantially Equivalent |