FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SITE SOLUTION ADMINISTRATION SET
K Number: K874725
·
Decision Apr 1, 1988
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
30
Review Days
135
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Basic Information
- Device Name
- SITE SOLUTION ADMINISTRATION SET
- K Number
- K874725
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Site Microsurgical Systems, Inc.
- Date Received
- November 18, 1987
- Decision Date
- April 1, 1988
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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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 |