FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAMPLING KIT
K Number: K801146
·
Decision Jun 4, 1980
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
5
Review Days
22
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Basic Information
- Device Name
- SAMPLING KIT
- K Number
- K801146
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Pharmaseal Laboratories
- Date Received
- May 13, 1980
- Decision Date
- June 4, 1980
- Product Code
- CBT
- 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 |
|---|---|---|---|
| CBT | Arterial Blood Sampling Kit | FDA class 1 | Anesthesiology |
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Other Clearances by Pharmaseal Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K800737 | DEBRISAN (DEXTRANOMER) PASTE | Aug 4, 1980 | Substantially Equivalent |
| K800874 | PELVIC EXAM TRAY | May 8, 1980 | Substantially Equivalent |
| K800362 | FLUID DISPENSING SYSTEM | Mar 12, 1980 | Substantially Equivalent |
| K760469 | CLEANSING AGENT, NEW WOUND (DEBRISSU) | Dec 16, 1976 | Substantially Equivalent |