FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GEN. PURPOSE INSTRUMENT TRAYS &
K Number: K833058
·
Decision Jan 31, 1984
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
4
Review Days
145
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Basic Information
- Device Name
- GEN. PURPOSE INSTRUMENT TRAYS &
- K Number
- K833058
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Inter-Med Corp.
- Date Received
- September 8, 1983
- Decision Date
- January 31, 1984
- 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 |
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HEART CATH TRAY
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