FDA 510(k)
Substantially Equivalent
🇺🇸 United States
STERILE EYE PACKS OR TRAYS
K Number: K852229
·
Decision Jun 7, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
10
Review Days
16
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Basic Information
- Device Name
- STERILE EYE PACKS OR TRAYS
- K Number
- K852229
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Surgeon Surgical Instrumentation, Inc.
- Date Received
- May 22, 1985
- Decision Date
- June 7, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- Third Party
- N
Other Clearances by Surgeon Surgical Instrumentation, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954241 | SURGIN GENISIS PHACOEMULSIFIER | Dec 1, 1995 | Substantially Equivalent |
| K932281 | VERRES NEEDLE | Aug 6, 1993 | Substantially Equivalent |
| K922038 | CO2 INSUFFLATION TUBING | Oct 13, 1992 | Substantially Equivalent |
| K904010 | SURGICAL ASPIRATOR KIT | Nov 21, 1990 | Substantially Equivalent |
| K890447 | HEMORRHAGE OCCLUDOR | Feb 23, 1989 | Substantially Equivalent |
| K880543 | UNI-PORT | Jul 1, 1988 | Substantially Equivalent |
| K881232 | SURGIN EYE SHIELD | Apr 13, 1988 | Substantially Equivalent |
| K861203 | MULTI-SPIKE | Apr 28, 1986 | Substantially Equivalent |
| K830859 | I/A KIT | May 2, 1983 | Substantially Equivalent |