FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED
K Number: K850150
·
Decision Feb 21, 1985
Classifications
1
FEI Numbers
157
Registration Numbers
157
Same Product Code
109
Applicant Total
11
Review Days
38
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Basic Information
- Device Name
- ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED
- K Number
- K850150
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4850
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Gainor Medical
- Date Received
- January 14, 1985
- Decision Date
- February 21, 1985
- Product Code
- FMK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Gainor Medical
| K Number | Device Name | ||
|---|---|---|---|
| K850100 | BLOOD LANCET | Jan 29, 1987 | Substantially Equivalent |
| K844306 | GAINOR MEDICAL SYRINGE | Nov 30, 1984 | Substantially Equivalent |
| K844305 | GAINOR MEDICAL FLOWMAX NEEDLES | Nov 30, 1984 | Substantially Equivalent |
| K840951 | FIRST AID BANDAGE | Oct 31, 1984 | Substantially Equivalent |
| K840950 | ZINC OXIDE TAPE | Oct 31, 1984 | Substantially Equivalent |
| K840945 | SKIN CLOSURE | Oct 31, 1984 | Substantially Equivalent |
| K840947 | CLOTH-HYPOALLERGENIC | Aug 17, 1984 | Substantially Equivalent |
| K840949 | CLEAR PLASTIC-HYPOALLERGENIC | Aug 17, 1984 | Substantially Equivalent |
| K840946 | MICROPOROUS HYPOALLERGENIC | Aug 17, 1984 | Substantially Equivalent |
| K840948 | CLEAR POROUS PLASTIC-HYPOALLERGENIC | Aug 14, 1984 | Substantially Equivalent |