FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMPCO-DRESSING CHANGE TRAY-MAJOR DC
K Number: K802964
·
Decision Jan 5, 1981
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
29
Review Days
45
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Basic Information
- Device Name
- AMPCO-DRESSING CHANGE TRAY-MAJOR DC
- K Number
- K802964
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Associated Medical Products Co.
- Date Received
- November 21, 1980
- Decision Date
- January 5, 1981
- 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
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SINGLE USE INSTRUMENT TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL INSTRUMENT TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARTHROSCOPY TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OPEN HEART TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HEART CATH TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Associated Medical Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K932221 | NEUROLOGICAL OR CRANI TRAYS (PACKS) | Mar 19, 1997 | Substantially Equivalent |
| K932216 | C-SECTION, LABOR & DELIVERY TRAYS (PACKS) | Apr 19, 1994 | Unknown |
| K930507 | CUSTOM ORTHOPAEDIC TRAYS (PACKS) | Feb 22, 1994 | Substantially Equivalent |
| K932217 | MAJOR, MINOR, BASIN TRAYS (PACKS) | Nov 15, 1993 | Unknown |
| K932220 | LAP CHOLY TRAYS (PACKS) | Sep 27, 1993 | Unknown |
| K932218 | CARDIAC CATH OR ANGIOGRAPHIC TRAYS | Aug 27, 1993 | Unknown |
| K932219 | SUTURE SET OR LACERATION TRAYS (PACKS) | Jul 9, 1993 | Unknown |
| K842983 | AMPCO OPTHALMIC TRAY | May 22, 1985 | Substantially Equivalent |
| K843114 | AMPCO PROCEDURE TRAYS / PACKS | Aug 8, 1984 | Unknown |
| K823839 | AMPCO KIDNEY DIALYSIS TRAY | Mar 29, 1983 | Substantially Equivalent |