FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTO-LANCET
K Number: K833344
·
Decision Nov 7, 1983
Classifications
1
FEI Numbers
157
Registration Numbers
157
Same Product Code
109
Applicant Total
9
Review Days
41
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Basic Information
- Device Name
- AUTO-LANCET
- K Number
- K833344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4850
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Palco Laboratories, Inc.
- Date Received
- September 27, 1983
- Decision Date
- November 7, 1983
- 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 Palco Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942810 | PALCO LABS COLD POUCH | Jun 28, 1995 | Substantially Equivalent |
| K943842 | PULSE OXIMETER MODEL 305 | Mar 24, 1995 | Substantially Equivalent |
| K920066 | PALCO LABS MODEL 340 PULSE OXIMETER | Mar 16, 1993 | Substantially Equivalent |
| K913694 | PALCO LABS LOADMATIC | Dec 17, 1991 | Substantially Equivalent |
| K911191 | PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR | Jun 10, 1991 | Substantially Equivalent |
| K904988 | PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR | Mar 18, 1991 | Substantially Equivalent |
| K872233 | INJECT-EASE | Sep 4, 1987 | Substantially Equivalent |
| K842547 | WET-STOP | Oct 19, 1984 | Substantially Equivalent |