FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPERATING ROOM TRAY SET
K Number: K840021
·
Decision Mar 15, 1984
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
12
Review Days
70
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Basic Information
- Device Name
- OPERATING ROOM TRAY SET
- K Number
- K840021
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medi-Plast Intl., Inc.
- Date Received
- January 5, 1984
- Decision Date
- March 15, 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 |
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
FDA 510(k)
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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
FDA 510(k)
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·General, Plastic Surgery
Other Clearances by Medi-Plast Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954284 | MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) | Feb 12, 1996 | Substantially Equivalent |
| K873588 | 10CC CONTROL SYRINGE | Oct 23, 1987 | Substantially Equivalent |
| K863402 | MEDI-PLAST DISPOSABLE MANIFOLD | Oct 22, 1986 | Substantially Equivalent |
| K861785 | FLUOROSCOPE BAND BAG | Jun 13, 1986 | Substantially Equivalent |
| K851489 | ARTERIAL-VENOUS COMPRESSION DRESSING | Jun 11, 1985 | Substantially Equivalent |
| K842136 | STERILE PAN SET | Jul 6, 1984 | Substantially Equivalent |
| K840022 | HEART CATHETERIZATION TRAY SET | Feb 4, 1984 | Substantially Equivalent |
| K811268 | BOTTLE-TO-BOTTLE | Jun 18, 1981 | Substantially Equivalent |
| K811234 | I.V. BOTTLE (RIDGID) | Jun 18, 1981 | Substantially Equivalent |
| K811233 | I.V. PLASTIC BAG | Jun 17, 1981 | Substantially Equivalent |