FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSTRUMENTS, GENERAL HAND & SURGERY
K Number: K760311
·
Decision Aug 9, 1976
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
303
Review Days
14
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Basic Information
- Device Name
- INSTRUMENTS, GENERAL HAND & SURGERY
- K Number
- K760311
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Depuy, Inc.
- Date Received
- July 26, 1976
- Decision Date
- August 9, 1976
- Product Code
- FSM
- 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 |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSM), ordered by most recent decision date.
INSTRUMENT TRAY LINER
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SINGLE USE INSTRUMENT TRAY
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SURGICAL INSTRUMENT TRAY
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ARTHROSCOPY TRAY
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OPEN HEART TRAY
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HEART CATH TRAY
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