FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFANT CANNULA
K Number: K873012
·
Decision May 2, 1988
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
24
Applicant Total
1
Review Days
272
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Basic Information
- Device Name
- INFANT CANNULA
- K Number
- K873012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Gresco International, Inc.
- Date Received
- August 4, 1987
- Decision Date
- May 2, 1988
- Product Code
- DQR
- 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 |
|---|---|---|---|
| DQR | Cannula, Catheter | FDA class 2 | Cardiovascular |
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