FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
K Number: K852402
·
Decision Jul 11, 1985
Classifications
1
FEI Numbers
526
Registration Numbers
526
Same Product Code
18
Applicant Total
28
Review Days
35
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Basic Information
- Device Name
- NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
- K Number
- K852402
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- North American Instrument Corp.
- Date Received
- June 6, 1985
- Decision Date
- July 11, 1985
- Product Code
- FZX
- 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 |
|---|---|---|---|
| FZX | Guide, Surgical, Instrument | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by North American Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K960801 | SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS) | Mar 29, 1996 | Substantially Equivalent |
| K955554 | HEMO-VALVE | Mar 4, 1996 | Substantially Equivalent |
| K960310 | EPIC INTRODUCER SHEATH | Feb 7, 1996 | Substantially Equivalent |
| K922552 | MORSE(R) ANGIOGRAPHIC CATHETERS | Mar 3, 1993 | Substantially Equivalent |
| K915078 | MORSE HEMOSTATIC CATHETER INTRODUCER SET | Jun 10, 1992 | Substantially Equivalent |
| K905208 | MORSE ANESTHESIA | Jan 10, 1992 | Substantially Equivalent |
| K912961 | MORSE VASCULAR INTRODUCER SET | Sep 11, 1991 | Substantially Equivalent |
| K910764 | THE PERCEPTOR(TM) STAND ALONE TRANSDUCER | Apr 22, 1991 | Substantially Equivalent |
| K903493 | NAMIC CONTRAST SAVINGS DELIVERY SYSTEM | Mar 26, 1991 | Substantially Equivalent |
| K904275 | MORSE BALLOON INFLATION DEVICE | Jan 3, 1991 | Substantially Equivalent |