FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS
K Number: K801331
·
Decision Aug 20, 1980
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
29
Review Days
78
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Basic Information
- Device Name
- AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS
- K Number
- K801331
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Associated Medical Products Co.
- Date Received
- June 3, 1980
- Decision Date
- August 20, 1980
- Product Code
- FRG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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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 |