FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRAY, SERVICE
K Number: K760497
·
Decision Nov 12, 1976
Classifications
1
FEI Numbers
285
Registration Numbers
286
Same Product Code
21
Applicant Total
13
Review Days
81
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Basic Information
- Device Name
- TRAY, SERVICE
- K Number
- K760497
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Landmark Plastics
- Date Received
- August 23, 1976
- Decision Date
- November 12, 1976
- Product Code
- LRP
- 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 |
|---|---|---|---|
| LRP | Tray, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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GENERAL SURGERY TRAY
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Other Clearances by Landmark Plastics
| K Number | Device Name | ||
|---|---|---|---|
| K760496 | CUP, DISPOSABLE SPECIMEN | Nov 12, 1976 | Substantially Equivalent |
| K760493 | DISH, SOAP | Nov 12, 1976 | Substantially Equivalent |
| K760492 | BASIN, LARGE OR SMALL | Nov 12, 1976 | Substantially Equivalent |
| K760490 | BEDPAN, GENERAL MEDICAL MEDI-PAK | Nov 12, 1976 | Substantially Equivalent |
| K760552 | THERMOMETER STAND AND DUST COVER | Nov 12, 1976 | Substantially Equivalent |
| K760494 | BASIN, ROUND WASH | Nov 12, 1976 | Substantially Equivalent |
| K760517 | CUP, DISPOSABLE MEDICINE | Nov 12, 1976 | Substantially Equivalent |
| K760495 | BASIN, RECTANGULAR WASH | Nov 12, 1976 | Substantially Equivalent |
| K760548 | CARAFE AND LINER | Nov 12, 1976 | Substantially Equivalent |
| K760491 | TUMBLER, GENERAL MEDICAL MEDI-PAK | Sep 15, 1976 | Substantially Equivalent |