FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMPCO OPTHALMIC TRAY
K Number: K842983
·
Decision May 22, 1985
Classifications
1
FEI Numbers
77
Registration Numbers
78
Same Product Code
46
Applicant Total
29
Review Days
296
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AMPCO OPTHALMIC TRAY
- K Number
- K842983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4790
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Associated Medical Products Co.
- Date Received
- July 30, 1984
- Decision Date
- May 22, 1985
- Product Code
- HOZ
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HOZ | Sponge, Ophthalmic | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HOZ), ordered by most recent decision date.
SUNTOUCH EYE SPEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
FDA 510(k)
FDA Class 2
·Ophthalmic
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
FDA 510(k)
FDA Class 2
·Ophthalmic
CENEFOM PVA SURGICAL SPEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
ULTRACELL ABSORBENT STICK
FDA 510(k)
FDA Class 2
·Ophthalmic
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
FDA 510(k)
FDA Class 2
·Ophthalmic
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 |
| K843114 | AMPCO PROCEDURE TRAYS / PACKS | Aug 8, 1984 | Unknown |
| K823839 | AMPCO KIDNEY DIALYSIS TRAY | Mar 29, 1983 | Substantially Equivalent |
| K821579 | SKIN SCRUB-TRAY | Jul 21, 1982 | Substantially Equivalent |