FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE
K Number: K883575
·
Decision Sep 12, 1988
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
3
Applicant Total
30
Review Days
21
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Basic Information
- Device Name
- MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE
- K Number
- K883575
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1860
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Site Microsurgical Systems, Inc.
- Date Received
- August 22, 1988
- Decision Date
- September 12, 1988
- Product Code
- HMG
- 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 |
|---|---|---|---|
| HMG | Stand, Instrument, Ophthalmic, Non-Powered | FDA class 1 | Ophthalmic |
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Other Clearances by Site Microsurgical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925828 | MODIFIED SITE TXR SYSTEMS | Feb 16, 1994 | Substantially Equivalent |
| K925921 | MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE | Dec 6, 1993 | Substantially Equivalent |
| K931866 | SITE'S CD II PHACOEMULSIFICATION HANDPIECE | Nov 12, 1993 | Substantially Equivalent |
| K921135 | IOLAB POWER I.V. POLE | Jun 3, 1992 | Substantially Equivalent |
| K920582 | 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. | May 8, 1992 | Substantially Equivalent |
| K912902 | PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE | Dec 17, 1991 | Substantially Equivalent |
| K912739 | SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE | Aug 28, 1991 | Substantially Equivalent |
| K910980 | SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE | May 22, 1991 | Substantially Equivalent |
| K905620 | MODIFIED SITE PERISTALTIC FOOTSWITCH | Feb 27, 1991 | Substantially Equivalent |
| K904183 | SITE PHACOEMULSIFICATION HANDPIECE | Dec 5, 1990 | Substantially Equivalent |