FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DILUTION KIT, THERMAL, COLD PAC
K Number: K781221
·
Decision Aug 23, 1978
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
50
Applicant Total
321
Review Days
37
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Basic Information
- Device Name
- DILUTION KIT, THERMAL, COLD PAC
- K Number
- K781221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Instrumentation Laboratory CO
- Date Received
- July 17, 1978
- Decision Date
- August 23, 1978
- Product Code
- DRC
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRC | Trocar | FDA class 2 | Cardiovascular |
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