FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CUI CHIN SIZER
K Number: K854339
·
Decision Nov 15, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
11
Review Days
18
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Basic Information
- Device Name
- CUI CHIN SIZER
- K Number
- K854339
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Cox-Uphuff Intl.
- Date Received
- October 28, 1985
- Decision Date
- November 15, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Cox-Uphuff Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K874276 | CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER | Dec 2, 1987 | Substantially Equivalent |
| K874342 | LIGATURE CARRIER/PACKER, HYDROXYLAPATITE | Nov 13, 1987 | Substantially Equivalent |
| K873470 | TEMPLATE | Sep 8, 1987 | Substantially Equivalent |
| K865056 | CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER | May 22, 1987 | Substantially Equivalent |
| K871200 | CUI NASAL SEPTUM BUTTON | Apr 15, 1987 | Substantially Equivalent |
| K865033 | BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER | Jan 12, 1987 | Substantially Equivalent |
| K853945 | CUI RHINOPLASTY IMPLANTS | Oct 18, 1985 | Substantially Equivalent |
| K831566 | CUI MAMMARY PROTHESIS SIZER | Aug 12, 1983 | Substantially Equivalent |
| K813394 | DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM | Jan 22, 1982 | Substantially Equivalent |
| K802214 | COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM | Oct 23, 1980 | Substantially Equivalent |