FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IV START TRAY
K Number: K820490
·
Decision Mar 16, 1982
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
29
Applicant Total
5
Review Days
21
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Basic Information
- Device Name
- IV START TRAY
- K Number
- K820490
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Seamless Hospital Products Co.
- Date Received
- February 23, 1982
- Decision Date
- March 16, 1982
- Product Code
- LRS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRS | I.V. Start Kit | FDA class 2 | General Hospital |
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Other Clearances by Seamless Hospital Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K841769 | INTERMITTENT URETHRAL CATHETER TRAY | Aug 24, 1984 | Substantially Equivalent |
| K823061 | BRUSH, SCRUB, OPERATING ROOM | Nov 5, 1982 | Substantially Equivalent |
| K821134 | DC PACK TM | Jun 22, 1982 | Substantially Equivalent |
| K781127 | CONNECTING TUBE, CONDUCTIVE, SURG. | Sep 20, 1978 | Substantially Equivalent |