FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXBORO-MEDICAL FOAM INSTRUMENT HOLDER
K Number: K953068
·
Decision Jan 23, 1996
Classifications
1
FEI Numbers
265
Registration Numbers
265
Same Product Code
270
Applicant Total
6
Review Days
207
Basic Information
- Device Name
- OXBORO-MEDICAL FOAM INSTRUMENT HOLDER
- K Number
- K953068
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- OXBORO MEDICAL INTL., INC.
- Date Received
- June 30, 1995
- Decision Date
- January 23, 1996
- Product Code
- KCT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | FDA class 2 | General Hospital |
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Other Clearances by OXBORO MEDICAL INTL., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K952787 | FOAM INSTRUMENT GUARD | Dec 28, 1995 | Substantially Equivalent |
| K952783 | OXBORO-MEDICAL PIN COVERS | Sep 15, 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 |