FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUCTION COLLECTION BOTTLE, DISPOSABLE
K Number: K810574
·
Decision Apr 21, 1981
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
47
Applicant Total
8
Review Days
49
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Basic Information
- Device Name
- SUCTION COLLECTION BOTTLE, DISPOSABLE
- K Number
- K810574
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Harvard Laboratories
- Date Received
- March 3, 1981
- Decision Date
- April 21, 1981
- Product Code
- KDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | FDA class 2 | General Hospital |
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Other Clearances by Harvard Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K822765 | SIGMOIDOSCOPE, FLEXIBLE | Nov 17, 1982 | Substantially Equivalent |
| K810573 | TUBE FEEDING SET | Apr 23, 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 |