FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK
K Number: K850050
·
Decision Apr 23, 1985
Classifications
1
FEI Numbers
77
Registration Numbers
78
Same Product Code
46
Applicant Total
19
Review Days
105
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Basic Information
- Device Name
- PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK
- K Number
- K850050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4790
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Professional Medical Services
- Date Received
- January 8, 1985
- Decision Date
- April 23, 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 |
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Other Clearances by Professional Medical Services
| K Number | Device Name | ||
|---|---|---|---|
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| K904508 | CONDOR ANALOG INFLATION SYRINGE | Apr 2, 1991 | Substantially Equivalent |
| K904954 | CONDOR DIGITAL INFLATION SYRINGE | Jan 16, 1991 | Substantially Equivalent |
| K902606 | RADIOPAQUE RULER | Sep 27, 1990 | Substantially Equivalent |
| K884577 | PROCEDURE READY TRAYS | Aug 1, 1989 | Unknown |
| K890471 | PMS ANGIO DRAPE | Feb 27, 1989 | Substantially Equivalent |
| K884497 | CONTROL SYRINGE | Dec 12, 1988 | Substantially Equivalent |
| K872448 | BLOOD CONTAINMENT PACK | Nov 17, 1987 | Substantially Equivalent |
| K864555 | 3 RING ATTACHMENT | Dec 1, 1986 | Substantially Equivalent |