FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTENSION SET
K Number: K896561
·
Decision Feb 1, 1990
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
28
Review Days
76
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Basic Information
- Device Name
- EXTENSION SET
- K Number
- K896561
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Westmark, Sterile Packing Systems, Inc. (Sps)
- Date Received
- November 17, 1989
- Decision Date
- February 1, 1990
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Westmark, Sterile Packing Systems, Inc. (Sps)
| K Number | Device Name | ||
|---|---|---|---|
| K896800 | IRRIGATION TRAY | May 24, 1990 | Unknown |
| K896799 | PARACERVICAL/PUDENDAL TRAYS | Apr 23, 1990 | Substantially Equivalent |
| K896559 | INFANT FEEDING TUBE | Mar 13, 1990 | Substantially Equivalent |
| K896794 | SPECIMEN CONTAINER | Mar 1, 1990 | Substantially Equivalent |
| K896806 | CATHETER PLUG/PROTECTOR | Feb 26, 1990 | Substantially Equivalent |
| K896798 | TRACHEOSTOMY TRAY | Feb 22, 1990 | Substantially Equivalent |
| K896797 | SUCTION CATHETER KIT | Feb 16, 1990 | Substantially Equivalent |
| K896215 | MERCY HIP/KNEE PACK | Feb 13, 1990 | Substantially Equivalent |
| K896804 | MANIFOLD | Feb 8, 1990 | Substantially Equivalent |
| K896556 | UNIVERSAL POOLE SUCTION TUBE | Feb 6, 1990 | Substantially Equivalent |