FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MULTIPLE PHARMA-PLAST TRACHEAL TUBE
K Number: K871263
·
Decision Jun 15, 1987
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
9
Review Days
76
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Basic Information
- Device Name
- MULTIPLE PHARMA-PLAST TRACHEAL TUBE
- K Number
- K871263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Pharma-Plast USA, Inc.
- Date Received
- March 31, 1987
- Decision Date
- June 15, 1987
- Product Code
- BTR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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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 |
| 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 |