FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
VARIOUS KITS AND TRAYS
K Number: K920292
·
Decision Jan 26, 1994
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
9
Review Days
735
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Basic Information
- Device Name
- VARIOUS KITS AND TRAYS
- K Number
- K920292
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Professional Medical Products, Inc.
- Date Received
- January 22, 1992
- Decision Date
- January 26, 1994
- Product Code
- LRO
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Professional Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926280 | STANDARD NEBULIZER HEATER | Mar 22, 1994 | Substantially Equivalent |
| K930270 | PATIENT PREOPERATIVE PREP TRAY, SINGLE USE | Feb 17, 1994 | Substantially Equivalent |
| K862010 | CHICK SURGICAL LIGHT | Jun 9, 1986 | Substantially Equivalent |
| K860739 | CHICK SURIGICAL LIGHT | Mar 28, 1986 | Substantially Equivalent |
| K834478 | CHICK/REISON PATIENT EMERG. TROLLEY | Feb 21, 1984 | Substantially Equivalent |
| K830825 | YIELD NON-ADHERENT DRESSING | May 13, 1983 | Substantially Equivalent |
| K822713 | DERM-A-TEC SKIN BARRIER FILM | Dec 7, 1982 | Substantially Equivalent |
| K820413 | AEGIS NON-ADHERENT DRESSING | Mar 12, 1982 | Substantially Equivalent |