FDA 510(k)
FDA class 1
Unknown
🇮🇱 Israel
KITS AND TRAYS FOR ONE TIME USE ONLY
K Number: K903963
·
Decision Jul 29, 1991
Classifications
1
FEI Numbers
285
Registration Numbers
286
Same Product Code
21
Applicant Total
2
Review Days
335
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Basic Information
- Device Name
- KITS AND TRAYS FOR ONE TIME USE ONLY
- K Number
- K903963
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Apk Technology
- Date Received
- August 28, 1990
- Decision Date
- July 29, 1991
- 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 |
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Other Clearances by Apk Technology
| K Number | Device Name | ||
|---|---|---|---|
| K903962 | INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE | Jul 29, 1991 | Unknown |