FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXBORO-MEDICAL PIN COVERS
K Number: K952783
·
Decision Sep 15, 1995
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
7
Applicant Total
6
Review Days
88
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Basic Information
- Device Name
- OXBORO-MEDICAL PIN COVERS
- K Number
- K952783
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oxboro Medical Intl., Inc.
- Date Received
- June 19, 1995
- Decision Date
- September 15, 1995
- Product Code
- LRN
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LRN | Wire, Surgical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRN), ordered by most recent decision date.
NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
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STAINLESS STEEL SOFT SUTURE WIRE
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J-FX CERCLAGE SYSTEM
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ORTHOPAEDIC WIRES
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TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)
FDA 510(k)
FDA Class 2
·Orthopedic
SONGER WIRING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Oxboro Medical Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953068 | OXBORO-MEDICAL FOAM INSTRUMENT HOLDER | Jan 23, 1996 | Substantially Equivalent |
| K952787 | FOAM INSTRUMENT GUARD | Dec 28, 1995 | Substantially Equivalent |
| K952784 | OXBORO-MEDICAL CAUTERY TIP CLEANER | Jul 13, 1995 | Substantially Equivalent |
| K880028 | OMED DISPOSABLE SCALPEL | Jan 29, 1988 | Substantially Equivalent |
| K874813 | OMED WOUND CLOSURE STRIPS | Jan 29, 1988 | Substantially Equivalent |