FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ORTHOPEDIC/NALEBUFF FINGER INSTRUMENTS
K Number: K831426
·
Decision Jun 8, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
18
Review Days
36
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Basic Information
- Device Name
- ORTHOPEDIC/NALEBUFF FINGER INSTRUMENTS
- K Number
- K831426
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- New England Surgical Instrument Corp.
- Date Received
- May 3, 1983
- Decision Date
- June 8, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
Other Clearances by New England Surgical Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K895337 | ELECTROSURGICAL COAGULATION SUCTION TUBE | Sep 15, 1989 | Substantially Equivalent |
| K895331 | ELECTROSURGICAL ELECTRODE | Sep 15, 1989 | Substantially Equivalent |
| K883963 | RANEY AND LEROY-RANEY SCALP CLIP | Oct 7, 1988 | Substantially Equivalent |
| K883396 | HANDSWITCHING MONOPOLAR PENCIL | Sep 13, 1988 | Substantially Equivalent |
| K880863 | BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200 | Apr 19, 1988 | Substantially Equivalent |
| K880859 | SURGICAL BURS | Mar 21, 1988 | Substantially Equivalent |
| K872271 | VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS | Jun 26, 1987 | Substantially Equivalent |
| K872209 | ARTHROPLASTY MALLET | Jun 23, 1987 | Substantially Equivalent |
| K864770 | SUCTION TUBE | Feb 24, 1987 | Substantially Equivalent |
| K864775 | CHISEL (OSTEOTOME, GOUGE, ETC.) | Feb 12, 1987 | Substantially Equivalent |