FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUBE FEEDING SET
K Number: K810573
·
Decision Apr 23, 1981
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
8
Review Days
51
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Basic Information
- Device Name
- TUBE FEEDING SET
- K Number
- K810573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Harvard Laboratories
- Date Received
- March 3, 1981
- Decision Date
- April 23, 1981
- Product Code
- KNT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Harvard Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K822765 | SIGMOIDOSCOPE, FLEXIBLE | Nov 17, 1982 | Substantially Equivalent |
| K810574 | SUCTION COLLECTION BOTTLE, DISPOSABLE | Apr 21, 1981 | Substantially Equivalent |
| K800879 | CLEAR PLASTIC CONNECTING TUBES | Jun 17, 1980 | Substantially Equivalent |
| K800877 | ANESTHESIA EXTENSION TUBES | Jun 17, 1980 | Substantially Equivalent |
| K800878 | SECONDARY I.V. TUBING SETS | Jun 17, 1980 | Substantially Equivalent |
| K800880 | PLASTIC TUBING ADAPTERS 5-IN-1- | May 14, 1980 | Substantially Equivalent |
| K800881 | DISPOSABLE BERMAN AIRWAYS | May 8, 1980 | Substantially Equivalent |