FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NIPRO DENTAL NEEDLE
K Number: K894373
·
Decision Oct 13, 1989
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
15
Applicant Total
9
Review Days
88
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Basic Information
- Device Name
- NIPRO DENTAL NEEDLE
- K Number
- K894373
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4730
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Pharma-Plast USA, Inc.
- Date Received
- July 17, 1989
- Decision Date
- October 13, 1989
- Product Code
- DZM
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZM | Needle, Dental | FDA class 1 | Dental |
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Other Clearances by Pharma-Plast USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K894371 | NIPRO SAFELET CATH | Oct 25, 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 |
| K852442 | PHARMA-PLAST NEEDLE | Sep 20, 1985 | Substantially Equivalent |